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Alopecia Treatment Market

Androgenetic Alopecia Pipeline Insight 2020

Androgenetic Alopecia – Pipeline Insight 2020

Androgenetic Alopecia pipeline insight, 2020 report outlays comprehensive insights of present clinical development scenario and growth prospects across the androgenetic alopecia market. A detailed picture of the androgenetic alopecia pipeline landscape is provided, which includes the disease overview and androgenetic alopecia treatment guidelines.

The assessment part of the report embraces in-depth androgenetic alopecia commercial assessment and clinical assessment of the androgenetic alopecia pipeline products from the pre-clinical developmental phase to the marketed phase.

In the report, a detailed description of the drug is proffered including mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, androgenetic alopecia collaborations, licensing, mergers and acquisition, funding, designations, and other product-related details.

The Report Provides Insights into:

All of the companies that are developing therapies for the treatment of androgenetic alopecia with aggregate therapies developed by each company for the same.
Different therapeutic candidates segmented into early-stage, mid-stage and late stages of development for the androgenetic alopecia treatment.
Androgenetic alopecia key players involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of androgenetic alopecia market.
The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, sec filings, investor presentations, and featured press releases from company/university web sites and industry-specific third-party sources, etc.

Androgenetic Alopecia Analytical Perspective

In-Depth Androgenetic Alopecia Commercial Assessment of Products

This report provides a comprehensive commercial assessment of therapeutic drugs that have been included, which comprises of collaborations, licensing, and acquisition deal value trends. The report also covers company-company collaborations (licensing/partnering), company-academia collaborations, and acquisition analysis in both graphical and tabulated form in a detailed manner.

Androgenetic alopecia clinical assessment of products

The report comprises of comparative clinical assessment of products by development stage, product type, route of administration, molecule type, and moa type across this indication.

Scope of the report

The androgenetic alopecia report provides an overview of therapeutic pipeline activity and therapeutic assessment of the products by development stage, product type, route of administration, molecule type, and moa type for androgenetic alopecia across the complete product development cycle, including all clinical and nonclinical stages.
It comprises of detailed profiles of androgenetic alopecia therapeutic products with key coverage of developmental activities, including technology, collaborations, licensing, mergers and acquisition, funding, designations and other product-related details
Detailed androgenetic alopecia research and development progress and trial details, results wherever available, are also included in the pipeline study.
Coverage of dormant and discontinued pipeline projects along with the reasons if available across androgenetic alopecia.

Report Highlights

A better understanding of disease pathogenesis contributing to the development of novel therapeutics for androgenetic alopecia.
in the coming years, the androgenetic alopecia market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
The companies and academics that are working to assess challenges and seek opportunities that could influence androgenetic alopecia R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
A detailed portfolio of major pharma players who are involved in fueling the androgenetic alopecia treatment market. Several potential therapies for androgenetic alopecia are under investigation. With the expected launch of these emerging therapies, it is expected that there will be a significant impact on the androgenetic alopecia market size in the coming years.
The in-depth analysis of the pipeline assets (in early-stage, mid-stage and late stage of development for the treatment of androgenetic alopecia ) includes therapeutic assessment and comparative analysis. This will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Key Questions

What are the current options for androgenetic alopecia treatment?
How many companies are developing therapies for the treatment of androgenetic alopecia?
What are the principal therapies developed by these companies in the industry?
How many therapies are developed by each company for the treatment of androgenetic alopecia?
How many androgenetic alopecia emerging therapies are in early-stage, mid-stage, and late stage of development for the treatment of androgenetic alopecia?
Out of total pipeline products, how many therapies are given as a monotherapy and in combination with other therapies?
What are the key collaborations (industry-industry, industry-academia), mergers and acquisitions, and major licensing activities that will impact androgenetic alopecia market?
Which are the dormant and discontinued products and the reasons for the same?
What is the unmet need for current therapies for the treatment of androgenetic alopecia?
What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing androgenetic alopecia therapies?
What are the clinical studies going on for androgenetic alopecia and their status?
What are the results of the clinical studies and their safety and efficacy?
What are the key designations that have been granted for the emerging therapies for androgenetic alopecia?
How many patents are granted and pending for the emerging therapies for the treatment of androgenetic alopecia?

Androgenetic Alopecia – Pipeline Insight 2020

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Alopecia Treatment Market

Androgenetic Alopecia Pipeline Insight 2020

Androgenetic Alopecia – Pipeline Insight 2020

Androgenetic Alopecia pipeline insight, 2020 report outlays comprehensive insights of present clinical development scenario and growth prospects across the androgenetic alopecia market. A detailed picture of the androgenetic alopecia pipeline landscape is provided, which includes the disease overview and androgenetic alopecia treatment guidelines.

The assessment part of the report embraces in-depth androgenetic alopecia commercial assessment and clinical assessment of the androgenetic alopecia pipeline products from the pre-clinical developmental phase to the marketed phase.

In the report, a detailed description of the drug is proffered including mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, androgenetic alopecia collaborations, licensing, mergers and acquisition, funding, designations, and other product-related details.

The Report Provides Insights into:

All of the companies that are developing therapies for the treatment of androgenetic alopecia with aggregate therapies developed by each company for the same.
Different therapeutic candidates segmented into early-stage, mid-stage and late stages of development for the androgenetic alopecia treatment.
Androgenetic alopecia key players involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of androgenetic alopecia market.
The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, sec filings, investor presentations, and featured press releases from company/university web sites and industry-specific third-party sources, etc.

Androgenetic Alopecia Analytical Perspective

In-Depth Androgenetic Alopecia Commercial Assessment of Products

This report provides a comprehensive commercial assessment of therapeutic drugs that have been included, which comprises of collaborations, licensing, and acquisition deal value trends. The report also covers company-company collaborations (licensing/partnering), company-academia collaborations, and acquisition analysis in both graphical and tabulated form in a detailed manner.

Androgenetic alopecia clinical assessment of products

The report comprises of comparative clinical assessment of products by development stage, product type, route of administration, molecule type, and moa type across this indication.

Scope of the report

The androgenetic alopecia report provides an overview of therapeutic pipeline activity and therapeutic assessment of the products by development stage, product type, route of administration, molecule type, and moa type for androgenetic alopecia across the complete product development cycle, including all clinical and nonclinical stages.
It comprises of detailed profiles of androgenetic alopecia therapeutic products with key coverage of developmental activities, including technology, collaborations, licensing, mergers and acquisition, funding, designations and other product-related details
Detailed androgenetic alopecia research and development progress and trial details, results wherever available, are also included in the pipeline study.
Coverage of dormant and discontinued pipeline projects along with the reasons if available across androgenetic alopecia.

Report Highlights

A better understanding of disease pathogenesis contributing to the development of novel therapeutics for androgenetic alopecia.
in the coming years, the androgenetic alopecia market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
The companies and academics that are working to assess challenges and seek opportunities that could influence androgenetic alopecia R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
A detailed portfolio of major pharma players who are involved in fueling the androgenetic alopecia treatment market. Several potential therapies for androgenetic alopecia are under investigation. With the expected launch of these emerging therapies, it is expected that there will be a significant impact on the androgenetic alopecia market size in the coming years.
The in-depth analysis of the pipeline assets (in early-stage, mid-stage and late stage of development for the treatment of androgenetic alopecia ) includes therapeutic assessment and comparative analysis. This will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Key Questions

What are the current options for androgenetic alopecia treatment?
How many companies are developing therapies for the treatment of androgenetic alopecia?
What are the principal therapies developed by these companies in the industry?
How many therapies are developed by each company for the treatment of androgenetic alopecia?
How many androgenetic alopecia emerging therapies are in early-stage, mid-stage, and late stage of development for the treatment of androgenetic alopecia?
Out of total pipeline products, how many therapies are given as a monotherapy and in combination with other therapies?
What are the key collaborations (industry-industry, industry-academia), mergers and acquisitions, and major licensing activities that will impact androgenetic alopecia market?
Which are the dormant and discontinued products and the reasons for the same?
What is the unmet need for current therapies for the treatment of androgenetic alopecia?
What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing androgenetic alopecia therapies?
What are the clinical studies going on for androgenetic alopecia and their status?
What are the results of the clinical studies and their safety and efficacy?
What are the key designations that have been granted for the emerging therapies for androgenetic alopecia?
How many patents are granted and pending for the emerging therapies for the treatment of androgenetic alopecia?

Androgenetic Alopecia – Pipeline Insight 2020

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Positive CTP-543 Results from Phase 2 Alopecia Areata Trial

Open Label Trial of CTP-543 in Patients with Alopecia Areata

Concert Pharmaceuticals Successfully Completes Open Label Trial of CTP-543 in Patients with Alopecia Areata

Concert Pharmaceuticals, Inc. today announced that it has completed its open label trial evaluating 8 mg twice-daily compared to 16 mg once-daily dosing of CTP-543 in patients with moderate-to-severe alopecia areata. Results in the 8 mg twice-daily arm were consistent with the previously-reported 8 mg twice-daily results from the Company’s Phase 2 trial of CTP-543. Treatment was generally well tolerated in both arms of the study. All but one of the patients who completed this trial have elected to continue in an open-label long-term extension study. The Company expects to report findings from the study at a future medical meeting

“Based on the results observed, the twice-daily regimen is preferred, and we intend to utilize it in our clinical development program for CTP-543 going forward,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “We believe that the findings from our dose regimen studies may be valuable to CTP-543’s intellectual property portfolio and therefore are not disclosing additional data from this study at this time.”

The dose regimen trial (NCT03811912) was a randomized, multi-center study to evaluate the efficacy and tolerability of once-daily versus twice-daily oral dosing of CTP-543, in adult patients with moderate-to-severe alopecia areata. Fifty-seven patients in the trial were randomized to receive CTP-543 either 8 mg twice-daily or 16 mg once-daily over a 24-week treatment period. The trial measured the relative change in Severity of Alopecia Tool (SALT) score between Week 24 and baseline.

Data from the Company’s Phase 2 trials will support an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to review and discuss the Company’s registration pathway for CTP-543 for the treatment of alopecia areata. The Company expects to meet with the FDA and initiate Phase 3 testing in 2020.

About CTP-543 and Alopecia Areata

CTP-543 is an oral selective inhibitor of Janus kinases JAK1 and JAK2. The FDA has granted Fast Track designation for CTP-543 for the treatment of alopecia areata.

Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 650,000 Americans at any given time1. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently no drugs approved by the FDA for the treatment of alopecia areata.

The FDA selected alopecia areata as one of eight new disease areas that it focused on under its Patient-Focused Drug Development Initiative (PFDDI) in 2016-2017. The goal of the PFDDI is to bring patient perspectives into an earlier stage of product development. Following the FDA’s Patient-Focused Drug Development meeting held in September 2017 on alopecia areata, the FDA summarized the input shared by patients and patient representatives in a Voice of the Patient report. Additional information on the PFDDI is available online.

About Concert

Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel medicines designed to treat serious diseases and address unmet patient needs. The Company’s approach starts with previously studied compounds, including approved drugs, in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert’s pipeline of innovative medicines targets autoimmune diseases and central nervous systems (CNS) disorders. For more information please visit www.concertpharma.com or follow us on Twitter at @ConcertPharma or on LinkedIn.

Concert Pharmaceuticals Successfully Completes Open Label Trial of CTP-543 in Patients with Alopecia Areata

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Alopecia Treatment Market

Global Androgenic Alopecia Drug Market

Global Androgenic Alopecia Drug Market Report 2019

Global Androgenic Alopecia Drug Market Report 2019With the slowdown in world economic growth, the Androgenic Alopecia Drug industry has also suffered a certain impact, but still maintained a relatively optimistic growth, the past four years, Androgenic Alopecia Drug market size to maintain the average annual growth rate of XXX from XXX million $ in 2014 to XXX million $ in 2018, our analysts believe that in the next few years, Androgenic Alopecia Drug market size will be further expanded, we expect that by 2023, The market size of the Androgenic Alopecia Drug will reach XXX million $.

This Report covers the manufacturers data, including: shipment, price, revenue, gross profit, interview record, business distribution etc., these data help the consumer know about the competitors better.

This report also covers all the regions and countries of the world, which shows a regional development status, including market size, volume and value, as well as price data.

Besides, the report also covers segment data, including: type segment, industry segment, channel segment etc. cover different segment market size, both volume and value.

Also cover different industries clients information, which is very important for the manufacturers.

Key manufacturers are included based on manufacturing sites, capacity and production, product specifications etc.:

Allergan, Inc.

Histogen, Inc.

R-Tech Ueno, Ltd.

Hygeia Therapeutics, Inc.

SWITCH Biotech LLC

Polichem S.A.

Kasiak Research Pvt. Ltd.

Region Segmentation

North America Country (United States, Canada)

South America

Asia Country (China, Japan, India, Korea)

Europe Country (Germany, UK, France, Italy)

Other Country (Middle East, Africa, GCC)

Product Type Segmentation

RK-023

Refagro

RCH-01

SM-04554

HYG-440

Industry Segmentation

Clinic

Hospital

Home Use

Global Androgenic Alopecia Drug Market Report 2019

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Cassiopea Announces First Patient to be Enrolled in Phase II Trial for Alopecia

Cassiopea Announces First Patient to be Enrolled in Phase II Trial for Alopecia

Cassiopea Announces First Patient to be Enrolled in Phase II Trial for the Treatment of Androgenetic Alopecia in Females with Clascoterone Solution

Cassiopea SpA, a specialty pharmaceutical company focused on developing and commercializing prescription drugs with novel mechanisms of action (MOA) to address long-standing and essential dermatological conditions, announced today that it has received approval from the German Authority BfArM and the coordinating ethical committee and will now proceed to enroll the first patient in a Phase II trial investigating clascoterone solution for the treatment of androgenetic alopecia (AGA) in females.

The Phase II multicenter, prospective, randomized, double-blind, vehicle controlled, dose ranging study will evaluate the efficacy and safety of clascoterone solution for the treatment of AGA in females. The six-month study will enroll approximately 280 female subjects between 18-55 years of age with mild to moderate AGA in Germany.

The four-arm study will enroll 70 subjects per arm in each of four treatment groups: clascoterone solution 5% BID (twice daily), clascoterone solution 7.5% BID (twice daily), minoxidil solution 2% BID (twice daily) and vehicle BID (twice daily). The co-primary endpoints are: (1) change from baseline in non-vellus Target Area Hair Count (TAHC) at month 6 in comparison to vehicle and (2) Hair Growth Assessment (HGA) score at month 6 in comparison to vehicle.

Clascoterone, a new chemical entity, is a proposed first-in-class topical androgen receptor inhibitor currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of acne (in a 1% cream) and in late stage development for the treatment of AGA (in a higher strength solution).

Laboratory studies suggest clascoterone competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles. Because of clascoterone’s likely local effect at the site of application, the risk of off-target, or systemic side effects, is minimized.

AGA is a leading cause of hair loss in men and women. In AGA, high local concentrations of DHT bind to androgen receptors within the scalp hair follicles, resulting in shortening of the hair cycle and gradual miniaturization of scalp follicles in men and women with a genetic predisposition.

Over time, these progressively smaller, thinner hair follicles are unable to produce new hair, thus resulting in AGA’s characteristic patterned baldness. DHT dependent effects are considered, in most cases, reversible, such that AGA could be responsive to medical treatment with clascoterone solution through its proposed MOA of direct inhibition of testosterone and DHT binding to local hair follicle androgen receptors. Clascoterone has the potential to be the only topical antiandrogen for use in both men and women with AGA if approved by the FDA.

Based on early clinical review, Cassiopea believes that topical clascoterone will not have the contraindications and safety warnings of an orally administered androgen modulator used for the treatment of AGA in men. It appears Clascoterone does not interfere with the hormonal and, in particular, testosterone profiles of male subjects; libido and sexual behavior changes have not been observed in clinical trials to date. Clascoterone is quickly metabolized to cortexolone, a metabolite with a known safety profile. Due to its rapid metabolism and local activity, there appears to be limited systemic exposure to clascoterone and thus potential systemic side effects are minimized.

On April 16, 2019, Cassiopea announced topline results from the Phase II Dose Ranging trial in males demonstrating statistically significant improvement versus vehicle for TAHC for each dose tested along with directional improvement for HGA at twelve months. No treatment-related serious adverse events among patients were recorded during the trial; local skin reactions, if present, were similar to vehicle and predominantly classified as mild.  Cassiopea has an End of Phase II Meeting with FDA scheduled on November 13, 2019, to discuss the AGA Phase III Program in males with clascoterone solution.

“Clascoterone, a unique topical androgen receptor inhibitor, has shown a remarkable increase in hair growth as compared to vehicle with minimal side effects in the Phase II Dose Ranging Study in males. If FDA approved, it will be a very welcomed and important therapy for female and male patterned hair loss, androgenetic alopecia,” said Wilma Bergfeld, Professor of Dermatology and Pathology at Cleveland Clinic and Past President, American Academy of Dermatology and American Society of Dermatopathology.

“If approved, clascoterone solution will be the first new mechanism of action for the treatment of androgenetic alopecia in decades, offering dermatologists and patients a new and potentially effective therapeutic alternative,” said Diana Harbort, CEO of Cassiopea. “We’re focused on the urgency to treat skin and scalp conditions that can leave not only physical scars, but also emotional scars. That’s why innovation is so critical. We are committed to finding a new pathway to treat the most common form of hair loss affecting both men and women.”

About Cassiopea

Cassiopea is a specialty pharmaceutical company focused on developing and commercializing prescription drugs with novel mechanisms of action to address long-standing and essential dermatological conditions, particularly acne, androgenetic alopecia and genital warts.

Cassiopea is investing in innovation that is driving scientific advancement in areas that have been largely ignored for decades. The portfolio comprises four unencumbered clinical candidates, for which Cassiopea owns the worldwide rights. If approved, Cassiopea plans to commercialize the products directly in the U.S. and partner the products for countries outside of the U.S. For further information on Cassiopea, please visit www.cassiopea.com.

About Clascoterone

Clascoterone, a new chemical entity, is a proposed first in class topical androgen receptor inhibitor under FDA review for the treatment of acne (in a 1% cream) and in late stage development for androgenetic alopecia (in a higher strength solution). Laboratory studies suggest clascoterone competes with androgens, specifically DHT, for binding to the androgen receptors within the sebaceous gland and hair follicles. When applied directly to the skin surface, clascoterone appears to target only local androgen receptors within the skin.  Because of clascoterone’s likely local effect at the site of application, the risk of off-target, or systemic side effects, is minimized.

Next events  

CS Small & Mid Cap Conference, Zurich
November 13, 2019

Jefferies Health Care Conference, London
November 20, 2019

Full-year results 2019
February 2020

Some of the information contained in this press release may contain forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cassiopea has no obligation to publicly update or revise any forward-looking statements.

Cassiopea Announces First Patient to be Enrolled in Phase II Trial for the Treatment of Androgenetic Alopecia in Females with Clascoterone Solution

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Global Alopecia Treatment Industry Research Report

Androgenic Alopecia Drug Market Research

Androgenic Alopecia Drug Market Research Report 2019

The global Androgenic Alopecia Drug market is valued at million US$ in 2018 is expected to reach million US$ by the end of 2025, growing at a CAGR of during 2019-2025.

This report focuses on Androgenic Alopecia Drug volume and value at global level, regional level and company level. From a global perspective, this report represents overall Androgenic Alopecia Drug market size by analyzing historical data and future prospect. Regionally, this report focuses on several key regions: North America, Europe, China and Japan.

At company level, this report focuses on the production capacity, ex-factory price, revenue and market share for each manufacturer covered in this report.

The following manufacturers are covered:

Allergan, Inc.
Histogen, Inc.
R-Tech Ueno, Ltd.
Hygeia Therapeutics, Inc.
SWITCH Biotech LLC
Polichem S.A.
Kasiak Research Pvt. Ltd.

Segment by Regions

North America
Europe
China
Japan

Segment by Type

RK-023
Refagro
RCH-01
SM-04554
HYG-440
Others

Segment by Application

Clinic
Hospital
Home Use

Androgenic Alopecia Drug Market Research Report 2019

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Concert Pharmaceuticals Presents Positive Phase 2 Data in Alopecia Areata

Concert Pharmaceuticals Presents Positive Phase 2 Data in Alopecia Areata During Late-Breaker Session at EADV Congress

Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today presented results from its recently completed Phase 2 dose-ranging trial of the investigational medicine CTP-543 in patients with moderate-to-severe alopecia areata, an autoimmune disorder that results in patchy or complete hair loss.

Patients in the study treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 met the primary efficacy endpoint with statistically significant differences (p <0.001) relative to placebo in the percentage of patients achieving a ≥ 50% relative change from baseline at 24 weeks using the Severity of Alopecia Tool (SALT). These results were presented during the 28th European Academy of Dermatology and Venereology (EADV) Annual Congress in Madrid, Spain.

    “We look forward to advancing the development of CTP-543 into Phase 3 evaluation next year, as we continue our efforts to bring a new treatment to patients with this serious autoimmune disorder that currently has no approved medications.”

“We are very pleased that we were selected to present our safety and efficacy data for CTP-543 to the treatment community at this Congress. We believe the results from this dose-ranging study with our oral JAK inhibitor, CTP-543, set a new bar for clinical results in patients with moderate-to-severe alopecia areata,” stated James V. Cassella, Ph.D., Concert’s Chief Development Officer, who made the oral presentation at EADV. “We look forward to advancing the development of CTP-543 into Phase 3 evaluation next year, as we continue our efforts to bring a new treatment to patients with this serious autoimmune disorder that currently has no approved medications.”

In the Phase 2 trial, the primary efficacy endpoint in the 12 mg twice-daily cohort was met with 58% of patients achieving a ≥ 50% relative reduction in their overall SALT score from baseline compared to 9% for placebo (p <0.001), with statistically significant separation from placebo occurring at Week 12.

In the 8 mg twice-daily cohort, 47% of patients achieved the primary endpoint compared to placebo (p <0.001). For the 4 mg cohort, 21% of patients achieved a ≥ 50% relative reduction in their overall SALT score from baseline, however there was not a statistically significant difference from placebo.

Data from the Patient Global Impression of Improvement scale showed 78% of the patients receiving 12 mg twice-daily and 58% of the patients receiving 8 mg twice-daily rated their alopecia areata as “much improved” or “very much improved” at Week 24. For both doses there was a statistically significant difference from placebo (p <0.001).

In the Phase 2 trial, the most common (≥10%) side effects in the 12 mg CTP-543 dose group were headache, nasopharyngitis, upper respiratory tract infection and acne.

One serious adverse event of facial cellulitis was reported as possibly related to treatment. After a brief dosing interruption, treatment was continued and this patient completed the trial. No thromboembolic events were reported during the trial.

The Phase 2 trial was a double-blind, randomized, placebo-controlled, sequential dose trial to evaluate the safety and efficacy of CTP-543 in adult patients with moderate-to-severe alopecia areata. A total of 149 patients were randomized to receive one of three doses of CTP-543 (4 mg, 8 mg, or 12 mg) or placebo, administered twice-daily.

The primary outcome measure utilized the SALT score after 24 weeks of dosing. The average baseline SALT score across all patients was approximately 88%, where 0% is no scalp hair loss and 100% represents total scalp hair loss. All patients who completed 24 weeks of treatment in the 12 mg dosing cohort had the opportunity to continue in a separate extension study to evaluate long-term safety and efficacy of CTP-543.

Details from the oral presentation, entitled “CTP-543, an oral JAK inhibitor, achieves primary endpoint in Phase 2 randomized, placebo-controlled, dose ranging trial in patients with moderate-to-severe alopecia areata,” is available in the Scientific Presentations section of Concert’s website.

About CTP-543 and Alopecia Areata

CTP-543 is an oral inhibitor of Janus kinases JAK1 and JAK2 for the potential treatment of alopecia areata. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CTP-543.

Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 650,000 Americans at any given time1.

The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently no drugs approved by the FDA for the treatment of alopecia areata.

The FDA selected alopecia areata as one of eight new disease areas that it focused on under its Patient-Focused Drug Development Initiative (PFDDI) in 2016-2017. The goal of the PFDDI was to bring patient perspectives into an earlier stage of product development. Following the FDA’s Patient-Focused Drug Development meeting held in September 2017 on alopecia areata, the FDA summarized the input shared by patients and patient representatives in a Voice of the Patient report. Additional information on the PFDDI is available online.

About Concert

Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel medicines designed to treat serious diseases and address unmet patient needs.

The Company’s approach starts with previously studied compounds, including approved drugs, in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert’s pipeline of innovative medicines targets autoimmune diseases and central nervous systems (CNS) disorders. For more information please visit www.concertpharma.com or follow us on Twitter at @ConcertPharma or on LinkedIn.

1 Fricke M. Epidemiology and Burden of alopecia areata: a systemic review. Clinical, Cosmetic and Investigational Dermatology. 2015; Vol 8. 397-403.

Concert Pharmaceuticals Presents Positive Phase 2 Data in Alopecia Areata During Late-Breaker Session at EADV Congress

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Male Androgenetic Alopecia

Global Alopecia Treatment Market Size

Global Alopecia Treatment Market Size, Status And Forecast 2019-2025

Alopecia is a term used to describe excessive hair damage under certain medical conditions or dietary issues.

Changing lifestyle along with increase in stress level among working class population is expected to boost the demand for treatment of hair loss globally. Furthermore, rise in geriatrics population along with high demand for surgical hair transplant is expected to drive the alopecia treatment market.

Increasing consumer disposable incomes and health awareness, emphasis to look good, and technological advancement in hair treatment medical devices are some other key drivers for this market. Since accessibility for scalp treatment is easily accessible and available, the demand for alopecia treatment has increased.

Though the market is expected to witness healthy growth during the forecast period, high cost of the medications and possible side effects/allergic reactions are acting as key barrier for alopecia market.
In 2018, the global Alopecia (Hair Loss)Treatment market size was xx million US$ and it is expected to reach xx million US$ by the end of 2025, with a CAGR of xx% during 2019-2025.

This report focuses on the global Alopecia (Hair Loss)Treatment status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Alopecia (Hair Loss)Treatment development in United States, Europe and China.

The key players covered in this study
Cipla
Dr. Reddy’s Laboratories
Regaine
Merck
Ranbaxy Laboratories
Vitabiotics
Nanogen
Alpecin
Johnson and Johnson

Market segment by Type, the product can be split into
Vitamins and Supplements
Shampoos and Conditioners
Others

Market segment by Application, split into
Men
Women
Children

Market segment by Regions/Countries, this report covers
United States
Europe
China
Japan
Southeast Asia
India
Central & South America

The study objectives of this report are:

To analyze global Alopecia (Hair Loss)Treatment status, future forecast, growth opportunity, key market and key players.
To present the Alopecia (Hair Loss)Treatment development in United States, Europe and China.
To strategically profile the key players and comprehensively analyze their development plan and strategies.
To define, describe and forecast the market by product type, market and key regions.

In this study, the years considered to estimate the market size of Alopecia (Hair Loss)Treatment are as follows:

History Year: 2014-2018
Base Year: 2018
Estimated Year: 2019
Forecast Year 2019 to 2025
For the data information by region, company, type and application, 2018 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

Global Alopecia Treatment Market Size, Status And Forecast 2019-2025

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Concert Pharmaceuticals to Provide Overview of Clinical Pipeline

Concert Pharmaceuticals to Provide Overview of Clinical Pipeline at Cantor Healthcare Conference

Concert Pharmaceuticals, Inc today announced that it will be providing an overview of the Company’s clinical pipeline following recent updates on the AVP-786 partnered program in a presentation at the Cantor Healthcare Conference on Thursday, October 3, 2019 at 5:20 p.m. ET in New York, NY.

“While we’re disappointed by the recent results generated by our collaborators in the AVP-786 Phase 3 Alzheimer’s agitation trial, we are highly focused on the distinct value of Concert’s proprietary drug candidates, CTP-543 for alopecia areata and CTP-692 for schizophrenia,” stated Roger Tung, Ph.D., President and CEO of Concert Pharmaceuticals.

“We have had a consistent pipeline strategy to develop innovative medicines based on well-established biology, which is the foundation for CTP-543, a JAK inhibitor for alopecia areata, and for CTP-692, a deuterated D-serine which is an NMDA co-agonist. Concert’s financial resources are dedicated to these proprietary candidates, and our clinical programs are focused on demonstrated efficacy and safety for unmet needs in these chronic diseases affecting millions of patients.”

Dr. Tung continued, “For our partnered programs, including AVP-786, the clinical rationale and all development costs are the responsibilities of our collaborators.” On September 27, 2019, Concert’s collaborator, Avanir Pharmaceuticals, Inc., announced that the second study of its Phase 3 clinical program for AVP-786 for the treatment of moderate-to-severe agitation in patients with Alzheimer’s disease did not meet its primary and key secondary endpoints.

At the Cantor Healthcare Conference, Dr. Tung will highlight recent developments and upcoming milestones for Concert’s two wholly-owned clinical candidates during the presentation.

CTP-543: an investigational treatment for moderate-to-severe alopecia areata

In September 2019, Concert reported positive topline results from a recently completed Phase 2 dose-ranging trial evaluating CTP-543 for the treatment of moderate-to-severe alopecia areata. CTP-543 achieved its primary endpoint in the 8 mg and 12 mg twice-daily dosing cohorts. Treatment with 8 and 12 mg twice-daily of CTP-543 for 24 weeks was generally well tolerated and resulted in significant hair regrowth and significant ratings of improvement in individuals with alopecia areata.

Concert plans to present the Phase 2 dose-ranging results in the late-breaking news session at the European Academy of Dermatology and Venereology (EADV) Annual Congress on October 12, 2019 in Madrid, Spain.

Concert also initiated two open-label studies in 2019 evaluating once-daily vs. twice-daily dosing. Both studies are fully enrolled. Topline data from the first study is expected by year-end 2019 and the results from the second study are expected in the first half of 2020.

The CTP-543 development program is based on well-established biology that Janus kinase (JAK) signaling underlies the pathophysiology in alopecia areata.
The Company intends to advance CTP-543 into Phase 3 in 2020.

About Concert

Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel medicines designed to treat serious diseases and address unmet patient needs. The Company’s approach starts with previously studied compounds, including approved drugs, in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert’s pipeline of innovative medicines targets autoimmune diseases and central nervous systems (CNS) disorders.

For more information please visit www.concertpharma.com or follow us on Twitter at @ConcertPharma or on LinkedIn.

Concert Pharmaceuticals to Provide Overview of Clinical Pipeline at Cantor Healthcare Conference

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Alopecia Treatment Market

Global Androgenic Alopecia Drug Market Insights

Global Androgenic Alopecia Drug Market Insights, Forecast to 2025

In 2017, the global Androgenic Alopecia Drug market size was  million US$ and is forecast to  million US in 2025, growing at a CAGR of  from 2018. The objectives of this study are to define, segment, and project the size of the Androgenic Alopecia Drug market based on company, product type, application and key regions.

This report studies the global market size of Androgenic Alopecia Drug in key regions like North America, Europe, Asia Pacific, Central & South America and Middle East & Africa, focuses on the consumption of Androgenic Alopecia Drug in these regions.

This research report categorizes the global Androgenic Alopecia Drug market by players/brands, region, type and application. This report also studies the global market status, competition landscape, market share, growth rate, future trends, market drivers, opportunities and challenges, sales channels, distributors and Porter’s Five Forces Analysis.

The various contributors involved in the value chain of Androgenic Alopecia Drug include manufacturers, suppliers, distributors, intermediaries, and customers. The key manufacturers in the Androgenic Alopecia Drug include
Allergan, Inc.
Histogen, Inc.
R-Tech Ueno, Ltd.
Hygeia Therapeutics, Inc.
SWITCH Biotech LLC
Polichem S.A.
Kasiak Research Pvt. Ltd.

Market Size Split by Type
RK-023
Refagro
RCH-01
SM-04554
HYG-440
Others

Market Size Split by Application
Clinic
Hospital
Home Use

Market size split by Region
North America
United States
Canada
Mexico
Asia-Pacific
China
India
Japan
South Korea
Australia
Indonesia
Singapore
Malaysia
Philippines
Thailand
Vietnam
Europe
Germany
France
UK
Italy
Spain
Russia
Central & South America
Brazil
Rest of Central & South America
Middle East & Africa
GCC Countries
Turkey
Egypt
South Africa

The study objectives of this report are:
To study and analyze the global Androgenic Alopecia Drug market size (value & volume) by company, key regions/countries, products and application, history data from 2013 to 2017, and forecast to 2025.
To understand the structure of Androgenic Alopecia Drug market by identifying its various subsegments.
To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).
Focuses on the key global Androgenic Alopecia Drug manufacturers, to define, describe and analyze the sales volume, value, market share, market competition landscape, SWOT analysis and development plans in next few years.
To analyze the Androgenic Alopecia Drug with respect to individual growth trends, future prospects, and their contribution to the total market.
To project the value and volume of Androgenic Alopecia Drug submarkets, with respect to key regions (along with their respective key countries).
To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.
To strategically profile the key players and comprehensively analyze their growth strategies.

In this study, the years considered to estimate the market size of Androgenic Alopecia Drug are as follows:
History Year: 2013-2017
Base Year: 2017
Estimated Year: 2018
Forecast Year 2018 to 2025

This report includes the estimation of market size for value (million US$) and volume (K Pcs). Both top-down and bottom-up approaches have been used to estimate and validate the market size of Androgenic Alopecia Drug market, to estimate the size of various other dependent submarkets in the overall market. Key players in the market have been identified through secondary research, and their market shares have been determined through primary and secondary research. All percentage shares, splits, and breakdowns have been determined using secondary sources and verified primary sources.

For the data information by region, company, type and application, 2017 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

Global Androgenic Alopecia Drug Market Insights, Forecast to 2025

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Concert Pharma’s CTP-543 trial for alopecia areata

Patient enrolment completed in Concert Pharma’s CTP-543 trial for alopecia areata

Concert Pharmaceuticals, Inc. (CNCE) today announced that it has completed patient enrolment of an open label clinical trial to evaluate once-daily 24 mg compared to twice-daily 12 mg oral dosing of CTP-543 in patients with alopecia areata. Topline data from this dose regimen trial is expected in the first half of 2020.

“We are extremely grateful to the patients who volunteer to participate in our clinical trials and support our mission to develop a new treatment for alopecia areata. These patients, along with the investigators and their teams who work together with us, are essential in the development of new treatment options alopecia areata,” said James V. Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals.

The open label trial (NCT03941548) is a randomized, multi-center study in the United States and Canada to evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543 in 66 adult patients with moderate-to-severe alopecia areata.

Patients in the trial were randomized to receive either 12 mg twice-daily or 24 mg once-daily of CTP-543 over a 24-week treatment period. The primary outcome measure is the relative change in Severity of Alopecia Tool (SALT) score at Week 24 from baseline. All patients who complete 24 weeks of treatment are eligible to enroll into a long term open label extension study of CTP-543.

Previously, the Company announced it has fully enrolled the first open label dose regimen trial evaluating 8 mg twice-daily compared to 16 mg once-daily of CTP-543 in patients with alopecia areata, with topline data from this trial expected in the fourth quarter of 2019.

Available data from the dose regimen trials along with Concert’s recently completed Phase 2 study of CTP-543 are intended to support an end of Phase 2 discussion with the U.S. Food and Drug Administration (FDA) in the first quarter of 2020.

Additional information about CTP-543 clinical trials are available on www.clinicaltrials.gov.

About CTP-543 Phase 2 Results

In September 2019, the Company reported topline results from its CTP-543 dose-ranging Phase 2 trial in patients with moderate-to-severe alopecia areata. At 24 weeks, patients treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 met the primary efficacy endpoint with statistically significant differences (p <0.001) relative to placebo in the percentage of patients achieving a ≥ 50% relative change from baseline at 24 weeks using the Severity of Alopecia Tool (SALT).

Both of these active dose groups were also significantly different from placebo in the number of patients achieving ≥ 75% and ≥ 90% relative change in SALT at Week 24 from baseline. At Week 24, patients treated with 8 mg twice-daily and 12 mg twice-daily CTP-543 also rated significantly greater improvement in their alopecia areata on the Patient Global Impression of Improvement Scale than did patients who received placebo. Treatment with CTP-543 was generally well tolerated.

The most common (≥10%) side effects in the 12 mg CTP-543 dose group were headache, nasopharyngitis, upper respiratory tract infection, and acne. One serious adverse event of facial cellulitis was reported; however, after a brief dose interruption, treatment was continued and this patient completed the trial. Additional information about the CTP-543 Phase 2 results is available in the Scientific Presentations section of Company’s website.

About CTP-543 and Alopecia Areata

CTP-543 is an oral selective inhibitor of Janus kinases JAK1 and JAK2 for the potential treatment of alopecia areata. The FDA has granted Fast Track designation for CTP-543 for the treatment of alopecia areata.

Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 650,000 Americans at any given time1. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently no drugs approved by the FDA for the treatment of alopecia areata.

Patient enrolment completed in Concert Pharma’s CTP-543 trial for alopecia areata

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