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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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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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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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Alopecia Treatment Market Insights

Global Androgenic Alopecia Drug Market Report 2019

Global Androgenic Alopecia Drug Market Report 2019

With 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.

Research 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.

Manufacturer Detail
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

Channel (Direct Sales, Distributor) Segmentation

Trend (2018-2023)

Product Type Detail

Downstream Consumer

Cost Structure

Conclusion

Global Androgenic Alopecia Drug Market Report 2019

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Treatment of alopecia universalis

Five updates for Alopecia Areata Awareness Month

Five updates for Alopecia Areata Awareness Month

Alopecia areata affects up to 6.8 million people in the U.S. and carries a 2.1% lifetime risk, according to the National Alopecia Areata Foundation. The foundation has dubbed September “Alopecia Areata Awareness Month” to increase awareness, spread empowerment and raise funds for research into this polygenic autoimmune disease.

In honor of this awareness month, Healio Dermatology has compiled the following recent articles that explore treatment pathways and the latest research in alopecia areata.

JAK inhibitor promotes hair growth in both men, women with androgenetic alopecia

Inflammation plays a key role in male and female pattern hair loss, Neal Walker, DO, president and CEO of Aclaris Therapeutics, said in an interview with Healio Dermatology regarding results from a phase 2 open-label clinical trial in patients with androgenetic alopecia. Read more

Top-line results show efficacy of LED cap for androgenetic alopecia

Data from a randomized, double-blind, placebo-controlled trial demonstrated that Revian Red – an LED cap for the treatment of androgenic alopecia — may stop hair loss and subsequently grow new hair, according to a press release. Read more

Systemic therapy with JAK inhibitors may be future of alopecia areata treatment

There are no reliable, effective therapies for severe disease in alopecia areata; however, systemically administered Janus kinase inhibitors hold potential for the treatment of the condition, as well as vitiligo, according to a presenter at the AAD Summer Meeting. Read more

Hidradenitis suppurativa increases risk for alopecia

In a study investigating the relationship between hidradenitis suppurativa and alopecia areata in a U.S. sample, those with hidradenitis suppurativa had a significantly higher risk for alopecia of any type and also lichen planopilaris. Read more

Cyclosporin ‘moderately effective’ at inducing remission of alopecia areata

Adults with moderate to severe alopecia areata treated with cyclosporin had a greater reduction in Severity of Alopecia Tool score over time when compared with a placebo group in a randomized trial. Read more

Alopecia Areata Awareness Month

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Positive CTP-543 Results from Phase 2 Alopecia Areata Trial

Positive CTP-543 Results from Phase 2 Alopecia Areata Trial

Concert Pharmaceuticals Reports Positive CTP-543 Results from Phase 2 Alopecia Areata Trial

Concert Pharmaceuticals, Inc. today announced final topline results from its recently completed dose-ranging Phase 2 trial evaluating its investigational medicine CTP-543 in patients with moderate-to-severe alopecia areata, an autoimmune disorder that results in patchy or complete hair loss.

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).

The 8 mg twice-daily and 12 mg twice-daily groups were also significantly different from placebo in the number of patients achieving ≥ 75% and ≥ 90% relative change in SALT from baseline at 24 weeks.

At Week 24, patients treated with 8 mg twice-daily and 12 mg twice-daily compared to placebo also rated significantly greater improvement in their alopecia areata on the Patient Global Impression of Improvement Scale. Treatment with CTP-543 was generally well tolerated. Complete study results are expected to be presented at a future medical meeting.

“We are very pleased with these clinical results and continue to believe CTP-543 has potential to be a best-in-class treatment for alopecia areata, a chronic dermatological autoimmune disease that currently has no approved therapies,” said James V. Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals. “We are highly focused on the need for an effective and safe treatment for alopecia areata, and we plan to advance CTP-543 into Phase 3 testing next year.”

“These Phase 2 results of CTP-543, a Janus kinase or JAK inhibitor, for the treatment of patients with alopecia areata are highly encouraging,” stated Dr. Brett King, Associate Professor of Dermatology at Yale School of Medicine. “There is a growing body of evidence supporting JAKs as a target for the treatment of alopecia areata that is driving enthusiasm in dermatology to address an important unmet need for patients.”

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). 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 these differences were not significantly different from placebo. In addition, 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 24 weeks of dosing, a significant difference from placebo.

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. 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; however, after a brief 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. 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.

About CTP-543 and Alopecia Areata

CTP-543 is an oral selective inhibitor of Janus kinases JAK 1 and JAK 2 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 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.

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

Concert Pharmaceuticals Reports Positive CTP-543 Results from Phase 2 Alopecia Areata Trial

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Global Hair Transplant Market

Global Hair Transplant Market Research Report 2018

Global Hair Transplant Market Research Report 2018

This report studies the global Hair Transplant market status and forecast, categorizes the global Hair Transplant market size (value & volume) by manufacturers, type, application, and region. This report focuses on the top manufacturers in North America, Europe, Japan, China, and other regions (India, Southeast Asia).

The global market size of Hair Transplant is $XX million in 2018 with XX CAGR from 2013 to 2018, and it is expected to reach $XX million by the end of 2025 with a CAGR of XX% from 2018 to 2023. The report presents the company profile, product specifications, capacity, production value, and 2013-2018 market shares for key vendor

The total market is further divided by company, by country, and by application/type for the competitive landscape analysis.

The major manufacturers of Hair Transplant Market covered in this report :-

Dermis Health Private Limited
Acibadem Hospitals Group
Medicamat
The Private Clinic
Bernstein Medical, P.C.
Advanced Hair Restoration
Limmer Hair Transplant Center
Bosley Inc.
Radiance
Mosaic Clinic Hair Transplant Center
Hair Transplants of Florida

The information for each major manufacturer/vendor includes:

– Company Profile
– Main Business Information
– SWOT Analysis
– Sales, Revenue, Price and Gross Margin
– Market Share

Geographically, this report studies the top producers and consumers, focuses on product capacity, production, value, consumption, Hair Transplant market share and growth opportunity in these key regions, covering-

North America
Europe
China
Japan
Southeast Asia
India

On the basis of product, this report displays the production, revenue, price, and market share and growth rate of each type, primarily split into-

Follicular Unit Extraction (FUE)
Follicular Unit Transplant (FUT)

Application of Hair Transplant Market are:

On the basis of the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, including

Hospitals
Trichology Clinics
Dermatology Clinics

The study objectives of this report are:

To analyse and study the global Hair Transplant capacity, production, value, consumption, status (2013-2017) and forecast (2018-2025);
Focuses on the key Hair Transplant manufacturers, to study the capacity, production, value, market share and development plans in future.
Focuses on the global key manufacturers, to define, describe and analyse the market competition landscape, SWOT analysis.
To define, describe and forecast the market by type, application and region.
To analyse the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
To identify significant trends and factors driving or inhibiting the Hair Transplant market growth.
To analyse the opportunities in the market for stakeholders by identifying the high growth segments.
To strategically analyse each submarket with respect to individual growth trend and their contribution to the Hair Transplant market
To analyse competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
To strategically profile the key players and comprehensively analyse their growth strategies.

In this study, the years considered to estimate the market size of Hair Transplant Market are as follows:-

History Year: 2013-2017
Base Year: 2017
Estimated Year: 2018
Forecast Year 2018 to 2025

No Of Pages:  118

Number of Tables and Figures: 146

The Hair Transplant Market report enables clients to:

– Boost revenues from new and existing customer base

– Identify key trends and hidden opportunities

– To identify the latest developments, Hair Transplant market shares, and strategies that are employed by the major market players.

– To know what is the Impact of opportunities that are offered by the Hair Transplant Market

– Design sustainable and competitive strategies in times of rapid development of Hair Transplant industry

– To analyze various market perspectives, with the help of Porter’s five forces analysis.

– To understand the regional analysis of the market.

– Understand paradigm shift in consumer preferences

Available Customizations with Additional charges

With the given market data, This Research offers customizations according to the company’s specific needs. The following customization options are available for the report:

Regional and country-level analysis of the Hair Transplant market, by end-use application.
Detailed analysis and profiles of additional market players.

Global Hair Transplant Market Research Report 2018

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Aclaris Therapeutics topical ATI-502

Aclaris Therapeutics Announces Phase 2 Clinical Trial of ATI-501

Aclaris Therapeutics Announces Phase 2 Clinical Trial of ATI-501 Oral in Patients with Alopecia Areata

Aclaris Therapeutics, Inc. (ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, today announced results from its Phase 2 clinical trial of ATI-501 (AUAT-201 Oral), an investigational oral Janus Kinase (JAK) 1/3 inhibitor, in subjects with alopecia areata (AA).

Subjects treated with ATI-501 achieved statistically significant improvement over placebo in several measures of hair growth, including the primary endpoint and certain secondary endpoints of the trial.

AUAT-201 Oral, a Phase 2 randomized, double-blinded, parallel-group, placebo-controlled trial, evaluated the safety, efficacy, and dose response of three doses of ATI-501 on the regrowth of hair in 87 subjects with AA, including Patchy Alopecia, Alopecia Totalis, and Alopecia Universalis.

Subjects with 30% to 100% total scalp hair loss were randomized in a 1:1:1:1 ratio and received 24 weeks of treatment, twice daily, with either 400 mg, 600 mg or 800 mg of ATI-501 or a placebo oral suspension.

The primary endpoint of the trial was the mean percent change from baseline in the Severity of Alopecia Tool (SALT) score at week 24.

Subjects in each of the three ATI-501 active dose groups (400 mg, 600 mg, and 800 mg) had statistically significant improvements compared to placebo for the primary endpoint (p=0.011, p=0.001, and p=0.010, respectively).

Secondary endpoints for which subjects in all three active treatment arms of the trial also achieved statistically significant improvements at 24 weeks compared to placebo included the following:

  • Absolute change in SALT scores from baseline: p<0.05 for all three ATI-501 doses;
  • Alopecia Density and Extent (ALODEX) percent change from baseline: p<0.05 for all three ATI-501 doses; and
  • ALODEX absolute change from baseline: p<0.01 for all three ATI-501 doses

Other exploratory secondary endpoints which were assessed were not statistically significant compared to placebo.

ATI-501 was observed to be generally well-tolerated at all doses.  There were no serious adverse events reported. All adverse events (AEs) were mild or moderate in severity and rates of AEs were similar across all groups. No thromboembolic events were observed in the study.  The most common AEs across all groups were: nasopharyngitis, influenza, upper respiratory tract infection, urinary tract infection, acne, blood creatine phosphokinase increased, and sinusitis.  Two subjects in each of the placebo and 400 mg groups and one subject in the 600 mg group had AEs leading to discontinuation of study drug, with no such AEs in the 800 mg group.

“We are pleased with these results, and we thank the patients and the investigators who participated in this trial,” said Dr. David Gordon, the Chief Medical Officer of Aclaris.

Company to Host Conference Call

Management will conduct a conference call at 5:00 PM ET today to review these Phase 2 results and related matters.  The conference call will be webcast live over the Internet and can be accessed by logging on to the “Investors” page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

About Alopecia Areata

Alopecia Areata (AA) is an autoimmune dermatologic condition typically characterized by patchy non-scarring hair loss on the scalp and body.  More severe forms of AA include total scalp hair loss, known as alopecia totalis, and total hair loss on the scalp and body, known as alopecia universalis.  The scalp is the most commonly affected area. Onset of AA may occur in childhood and most patients experience onset by age 40. The course of disease is unpredictable and may involve spontaneous hair regrowth and sudden hair loss. Over half of patients with AA experience poor health-related quality of life. The disease can be associated with serious psychological consequences, including anxiety and depression. AA affects up to 1.8% of people in the United States and 2.0% of people globally at some point during their lives.

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of people with immuno-inflammatory and dermatological diseases who lack satisfactory treatment options.

The company’s diverse and multi-stage portfolio includes two FDA-approved medicines, one late-stage investigational medicine, and a pipeline powered by a robust R&D engine exploring protein kinase regulation. Aclaris Therapeutics’ active development programs focus on areas where significant treatment gaps exist, such as common warts, alopecia areata, and vitiligo.

For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

Aclaris Therapeutics Announces Phase 2 Clinical Trial of ATI-501 Oral in Patients with Alopecia Areata

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Alopecia Treatment Market

Alopecia Medication Market 2019

Alopecia Medication(Hair Loss) Market 2019 Global Trends, Share, Growth, Analysis, Opportunities and Forecast To 2026

A new market study, titled “Discover Global Alopecia Medication(Hair Loss) Market Upcoming Trends, Growth Drivers and Challenges” has been featured on WiseGuyReports.
Introduction

Global Alopecia Medication(Hair Loss) Market

This report presents a study of the Alopecia Medication(Hair Loss) Market for the review period 2026. It also includes a market factor analysis comprising Porter’s five-factor analysis and supply chain analysis. A segmental breakdown of the market is added for a deeper understanding of the market mechanism.

Key Players:

Key players are adopting strategies such as mergers and acquisitions, partnerships, and regional expansion to stand out as strong competitors in the market. Regulatory approvals along with increased focus on R&D are other ways the leading players improve their market presence.

The noted participants of the market have been studied in details in this report for covering an in-depth share analysis of the Alopecia Medication(Hair Loss) Market. The analysis includes an assessment of the growth strategies implemented by these players in the market.

Some of these strategies are mergers & acquisition, collaboration, rising investments, partnership, product portfolio development, etc. In addition, the increasing research & development activities are further expected to impact the growth of the Alopecia Medication(Hair Loss) Market favorably in the forthcoming years.

Global Alopecia Medications Market – Market Dynamics

The global Alopecia Medications market is primarily driven by the high prevalence of the Alopecia worldwide. According to National Alopecia Areata Foundation, Alopecia areata is a common autoimmune disease that occurs in males and females of all ages and races, but onset most often occurs in childhood and approximately 147 million worldwide have or will develop alopecia areata at some point in their lives.

A meta-analysis study suggests that androgenetic alopecia, a genetically predetermined disorder due to excessive response to androgens, affects up to 50% of males and females. Furthermore, various launch, approvals, and pipeline of alopecia medications products are expected to drive the growth of market

For instance, in January 2018, Concert Pharmaceuticals received a Fast Track designation from the U.S. FDA for its unique product CTP-543, an oral Janus kinase inhibitor for the medications of moderate-to-severe alopecia areata.

However, the patent expiry of many blockbuster drugs and side effects associated with the available hair loss medications therapies may hinder the market progress over the forecast period.

Global Alopecia Medications Market – Segment Analysis

By Alopecia type, the global Alopecia market is segmented into androgenic alopecia, alopecia areata, ciatricial alopecia, traction alopecia, and alopecia totalis. The androgenetic alopecia segment is the most significant share owing to it high prevalence among the different types of alopecias.

Androgenetic alopecia is a common form of hair loss in both men and women. In men, this condition is also known as male-pattern baldness. According to the American Hair Loss Association, androgenetic alopecia accounts for over 95% of hair loss in men.

By Drug type, the global Alopecia market is segmented into minoxidil, finasteride, corticosteroids, immunosuppressants (cyclosporine, and others). The Finasteride holds a significant segment for the medications of alopecia. However, the U.S. FDA proved two drugs Minoxidil, and finasteride to treat Alopecia and the American Hair Loss Association recommends the use of minoxidil in patients who have not responded to finasteride medications. Hence the Minoxidil segment is fast rising.

By Gender, the global Alopecia market is segmented into male and female. Males hold a substantial segment. According to American Hair Loss Association (AHLA) by the age of 35, two-thirds of American men will experience some degree of appreciable hair loss, and by the age 50, approximately 85% of men have significantly thinning hair and females make up 40% of American hair loss sufferers.

Drivers and Restraints:

Every key micro and macroeconomic factor has been assessed in this report for throwing light on the drivers an restraints. Quantification of the magnitude of impact of these factors on the market valuation is also included in the report for keeping the client ahead of the curve.

Regional Description:

The regions covered for providing an exhaustive study of the Alopecia Medication(Hair Loss) Market are – South America, Europe, Asia Pacific, North America, and the Middle East & Africa. In addition, the study also includes an assessment of the market on a country-level basis for highlighting the opportunities and threats.

Method of Research:

Cutting edge algorithms and research methodologies are leveraged for the extrapolation of market shifts. A detailed research method (including both primary & secondary) has been undertaken for the collection of data. The primary sources include interviews with top-level executives across the value chain (CEOs, VPs, MDs, etc.), surveys, questionnaires, etc.

And, the secondary sources referred to are SEC filings, whitepaper references, published reports, governments documents, etc. The collected data is passed through a multi-layer verification process for assuring the quality of the insight offered. Top-down and bottom-up approaches are utilized for ensuring the authenticity and credibility of the valuations of the markets and segments.

Alopecia Medication(Hair Loss) Market 2019 Global Trends, Share, Growth, Analysis, Opportunities and Forecast To 2026

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PRP Workshop To Enhance Hair Restoration

Global Platelet Rich Plasma and Stem Cell Alopecia Treatment Market

Global Platelet Rich Plasma & Stem Cell Alopecia Treatment Market- Snapshot

The global platelet rich plasma & stem cell alopecia treatment market is expected to reach a value of approximately US$ 450.5 Mn by the end of 2026, expanding at a high single digit CAGR during the forecast period. Factors such as increase in demand for accurate and prompt treatment of alopecia and advancements in platelet rich plasma and stem cell therapies that have revolutionized the diagnostic science are likely to boost the market.

Moreover, a rise in awareness about platelet rich plasma therapies and stem cell therapies is expected to drive the global market during the forecast period. Increased awareness has driven demand for platelet rich plasma therapy & stem cell therapy in the past few years in countries such as Japan, India, Brazil, and Russia and developed regions such as North America and Europe. Additionally, private players are actively promoting the advantages of treatment of alopecia with stem cell therapy across the globe.

A rise in the incidence rates of autoimmune hair loss disorders such as alopecia is estimated to boost the platelet rich plasma & stem cell alopecia treatment market. According to the Journal of Clinical, Cosmetic, and Investigational Dermatology, 2015, the lifetime incidence rate of alopecia areata is approximately 2% worldwide.

Global Platelet Rich Plasma & Stem Cell Alopecia Treatment Market

This is expected to propel the market. However, a lack of treatment approval and high cost of alopecia treatment are likely to hinder the growth of platelet rich plasma & stem cell alopecia treatment market.

The global platelet rich plasma & stem cell alopecia treatment market has been segmented based on treatment, indication, end-user, and region. In terms of treatment, the global market has been classified into platelet rich plasma therapies and stem cell therapy.

The platelet rich plasma therapies segment held a major market share and is expected to expand at a significant CAGR, owing to the effectiveness of the therapies in the treatment of many types of alopecia. Platelet rich plasma therapies have revolutionized alopecia treatment by reducing costs, treatment duration, and recovery time for patients. The stem cell therapy segment has been further divided into bone marrow and adipose.

Based on indication, the global platelet rich plasma & stem cell alopecia treatment market has been divided into androgenic alopecia, congenital alopecia, cicatricial or scarring alopecia, and others. The androgenic alopecia segment holds a key market share as androgenic alopecia is the most common cause of hair loss in both men and women. About 45% men and 35% women develop androgenic alopecia by 60, which is the highest among all the types of alopecia.

A study published in the International Journal of Women’s Dermatology in 2019 revealed that the use of PRP to treat androgenic alopecia is promising due to its autologous nature, minimal invasiveness, lack of major side effects, and low cost compared to hair restoration surgery.

In terms of end-user, the global market has been categorized into hospitals, dermatology clinics, and others. The dermatology clinics segment held a major share of the market, followed by the hospital segment, in 2017.

This is due to an increase in preference among patients for dermatology clinics where they can avail combined treatment for hair, skin, and nails. Moreover, an increase in incidence of alopecia, rise in access to dermatologists, and surge in awareness about services provided by dermatology clinics are factors attributable to the high market share of the segment.

Certain hospitals have diagnostic facilities, including hair & scalp computerized analysis, in-house laboratory, and a number of different treatment options. This is likely to boost the global market, especially in developing regions.

In terms of region, the global platelet rich plasma & stem cell alopecia treatment market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominates the global platelet rich plasma & stem cell alopecia treatment market, owing to high rate of adoption of advanced products and rise in market penetration of new market entrants with novel technology in the region.

Moreover, high prevalence of alopecia in the region is imposing a significant economic burden and is boosting demand for affordable care. This, in turn, is driving demand for platelet rich plasma & stem cell alopecia treatment.

According to the National Institute of Health in 2015, 95% of women suffer from androgenetic alopecia in the U.S.. This has led the country to dominate the platelet rich plasma & stem cell alopecia treatment market in North America.

The U.S. is anticipated to maintain its leading position in the market in the region during the forecast period. Additionally, increased application of PRP for the treatment of alopecia has been observed in the past few years.

This is likely to fuel the market in the region. The market in Asia Pacific is projected to expand at a significantly high CAGR during the forecast period, owing to the emergence of strong local manufacturers offering various technological advancements for platelet rich plasma & stem cell alopecia treatment at lower prices and increase in awareness among people about these treatment methods. Furthermore, an increase in health care expenditure and investments by key players in emerging regions such as China and India are estimated to fuel the market in the region.

Major players operating in the global platelet rich plasma & stem cell alopecia treatment market include Kerastem, Eclipse, Regen Lab SA, Stemcell Technologies, Inc., RepliCel Life Sciences, Histogen, Inc., and Glofinn Oy.

Key players are focused on research & development of alopecia treatment by investing in platelet rich plasma & stem cell alopecia therapies. Mergers & acquisitions, collaborations, and partnerships are helping companies expand their footprint and further develop effective treatments for alopecia.

Global Platelet Rich Plasma & Stem Cell Alopecia Treatment Market- Snapshot

 

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Male Androgenetic Alopecia

Global Alopecia Market Insights

Global Alopecia (Hair Loss Treatment) Market Insights, Forecast to 2025

The global Alopecia (Hair Loss Treatment) market is valued at million US$ in 2018 and will reach million US$ by the end of 2025, growing at a CAGR of during 2019-2025. The objectives of this study are to define, segment, and project the size of the Alopecia (Hair Loss Treatment) market based on company, product type, end user and key regions.

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

This research report categorizes the global Alopecia (Hair Loss Treatment) market by top players/brands, region, type and end user. This report also studies the global Alopecia (Hair Loss Treatment) market status, competition landscape, market share, growth rate, future trends, market drivers, opportunities and challenges, sales channels and distributors.

The following manufacturers are covered in this report, with sales, revenue, market share for each company:

Shiseido
Rohto
Unilever
Taisho
Angfa
LOreal
Kaminomoto
Merck
Yanagiya Honten
Amorepacific
Procter & Gamble
Himalaya
Gerolymatos International
Merz Pharma
Leader Teck
Vasu Healthcare
VLCC
Ales Group
Shanxi Ante
Wansheng Pharmaceutical
Advanced Skin and Hair
Humanwell Healthcare
Topfond
Lifes2good
Bawang
YNK Pharmaceutical
Apollo
Jingxiutang
Rogaine
Marico

Market size by Product

Shampoos and Conditioners
Medicine Product
Market size by End User
Men
Women

Market size 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 Alopecia (Hair Loss Treatment) market size (value & volume) by company, key regions, products and end user, breakdown data from 2014 to 2018, and forecast to 2025.
To understand the structure of Alopecia (Hair Loss Treatment) 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 Alopecia (Hair Loss Treatment) companies, to define, describe and analyze the sales volume, value, market share, market competition landscape and recent development.
To project the value and sales volume of Alopecia (Hair Loss Treatment) submarkets, with respect to key regions.
To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.

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

This report includes the estimation of market size for value (million US$) and volume (K Units). Both top-down and bottom-up approaches have been used to estimate and validate the market size of Alopecia (Hair Loss Treatment) 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, 2018 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

Global Alopecia (Hair Loss Treatment) Market Insights, Forecast to 2025

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