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Aclaris Therapeutics Announces Positive Interim Data from Phase 2 study of ATI-502

Aclaris Therapeutics Announces Positive Interim Data from Phase 2 study of ATI-502

Aclaris Therapeutics Announces Positive Interim Data from Phase 2 study of ATI-502 (a topical JAK inhibitor) in Patients with Alopecia Areata

Aclaris Therapeutics, Inc, a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, today announced positive interim data from its Phase 2 clinical trial (AA-202 Topical) of ATI-502 for the treatment of Alopecia Totalis (AT) or Alopecia Universalis (AU), the more severe variants of Alopecia Areata (AA).

ATI-502, an investigational topical Janus Kinase (JAK) 1/3 inhibitor (ATI-502) is the most advanced topical JAK inhibitor in clinical trials for AT/AU in the United States.

This randomized, double-blind clinical trial is being conducted at 2 study sites and will evaluate the pharmacokinetics, pharmacodynamics, and safety of ATI-502 compared with vehicle in 11 patients with AT or AU over 28 days of treatment, followed by a 6-month open-label period when all patients receive the drug.

AA is an autoimmune dermatologic condition typically characterized by patchy non-scarring hair loss on the scalp and body. More severe forms of AA are characterized by a total scalp hair loss (AT) or total hair loss on the scalp and body (AU).

Today, we report interim results for 6 of the 11 enrolled patients; data from the full cohort will be reported in the future.

Pharmacokinetic Results:

Systemic exposure was low as indicated by plasma drug levels that were below the limits of quantification (1ng/ml) in all subjects at day 28.
• Consistent with low systemic exposure, no significant changes in circulating T, B and NK cells were observed at day 28.
To assess skin penetration, punch biopsies were obtained at baseline and day 28 which demonstrated topical ATI-502 absorption consistent with pre-clinical skin models.
• Mean of 5650 nanograms/gram at day 28 (range 3130 – 8170 ng/g).
Pharmacodynamic / RNA Sequencing Results:

2 patients had marked elevation of the interferon gamma and cytotoxic T-cell gene expression signatures at baseline: one received active drug and one received vehicle. At day 28, the patient on active drug demonstrated a positive change in the 2 biomarkers, while the patient on vehicle did not demonstrate a positive change in the 2 biomarkers.
2 patients had low elevation of the interferon gamma and cytotoxic T-cell gene expression signatures at baseline: one received active drug, one received vehicle. At day 28 both patients showed a partial positive change in the 2 biomarkers.
2 patients had no elevation of the interferon gamma and cytotoxic T-cell gene expression signatures at baseline: both patients received active drug. At day 28, neither patient showed any material change in the 2 biomarkers.
Safety

No serious adverse events (SAEs) were reported during the 28-day dosing period. One subject receiving ATI-502 withdrew from the trial due to an unrelated SAE of major depression during the open-label extension period.
Key Results Summary

This data is the first indication that ATI-502 is absorbed through the human skin in the clinical setting and engages the target. The results also demonstrate the pharmacodynamic effect of modulating the appropriate genes associated with the interferon-gamma pathway and cytotoxic T-lymphocytes, which are 2 of 3 biomarker components of the Alopecia Areata Disease Activity Index (ALADIN) score.

Our hypothesis is this response can be predicted by a patient’s baseline genetic signature.

“This is the first time we have demonstrated that Topical ATI-502 is positively impacting the genetic signature implicated in alopecia areata,” said Stuart Shanler, M.D., Chief Scientific Officer of Aclaris Therapeutics, Inc.

Aclaris Therapeutics topical ATI-502

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in dermatology, both aesthetic and medical, and immunology. Aclaris’ focus on market segments with no FDA-approved medications or where treatment gaps exist has resulted in the first FDA-approved treatment for raised seborrheic keratoses and several clinical programs to develop medications for the potential treatment of common warts, alopecia areata, and vitiligo. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn.

About Alopecia Areata

Alopecia areata is an autoimmune disease that results in partial or complete loss of hair on the scalp and body. 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. AA can be associated with serious psychological consequences, including anxiety and depression. AA affects up to 2.0% of people globally at some point during their lifetime (i.e. incidence) and up to 0.2% of people are affected at any given time (i.e. prevalence). There are currently no drugs approved by the FDA for the treatment of AA.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding Aclaris’ clinical development of its JAK inhibitor drug candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements.

Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2017, Aclaris’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “Financial Information” section of the Investors page of Aclaris’ website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Aclaris Therapeutics Announces Positive Interim Data from Phase 2 study of ATI-502

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Aclaris Therapeutics topical ATI-502

 

Global Alopecia Drugs Market Insights Report

Phase 2 Clinical Trial of ATI-501 Oral Suspension in Patients with Alopecia

Aclaris Therapeutics Announces First Patient Dosed in a Phase 2 Clinical Trial of ATI-501 Oral Suspension in Patients with Alopecia Totalis and Alopecia Universalis

Aclaris Therapeutic, a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, today announced that the first patient has been dosed in Aclaris’ Phase 2 clinical trial of its JAK inhibitor product candidate ATI-501 oral suspension in patients with two forms of Alopecia Areata (AA) known as Alopecia Totalis (AT) and Alopecia Universalis (AU).

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 AT, which is total scalp hair loss, and AU, which is total hair loss on the scalp and body.

This multicenter, randomized study, known as AUAT-201, will evaluate the safety, tolerability, and efficacy of ATI-501 oral suspension for the treatment of AU or AT in adult subjects. Aclaris intends to enroll approximately 80 subjects with a clinical diagnosis of stable AU or AT. Enrolled subjects will receive either ATI-501 or placebo for 6 months.

The primary efficacy endpoint is the mean change from baseline in the Severity of Alopecia Tool (SALT) score at Week 24. Secondary and exploratory endpoints include the change from baseline in the Alopecia Density and Extent Score (ALODEX) score and various clinician and patient-reported outcomes.

“This trial is the first step in evaluating the potential clinical benefit of ATI-501 oral suspension in treating patients with the alopecia totalis and alopecia universalis forms of alopecia areata,” said Dr. Stuart Shanler, Chief Scientific Officer of Aclaris. “This is an important step forward in understanding the clinical utility of our JAK inhibitors in patients with AA.”

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in dermatology, both aesthetic and medical, and immunology.

Aclaris’ focus on market segments with no FDA-approved medications or where treatment gaps exist has resulted in the first FDA-approved treatment for raised seborrheic keratoses and several clinical programs to develop medications for the potential treatment of common warts, alopecia areata, and vitiligo. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn.

About Alopecia Areata

Alopecia areata is an autoimmune disease that results in partial or complete loss of hair on the scalp and body. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp.

The onset of the disease can occur throughout life and affects both women and men. AA can be associated with serious psychological consequences, including anxiety and depression.

AA affects up to 2.0% of people globally at some point during their lifetime (i.e. incidence) and up to 0.2% of people are affected at any given time (i.e. prevalence). There are currently no drugs approved by the FDA for the treatment of AA.

Phase 2 Clinical Trial of ATI-501 Oral Suspension in Patients with Alopecia

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Alopecia Market Pipeline Revive H1 Therapeutics

Hair Loss and Balding in Women

Hair Loss and Balding in Women

Hair Loss and Balding in Women: Lilac Corp Reviews a Study and Recommends Nolopecia for Hair Growth in Women

All natural hair loss supplement sold by Lilac Corp —

Lilac Corp discusses a study on a new discovery that links the ANGPT2 gene and hair loss and recommends Nolopecia, a natural treatment for hair growth in women.

There are many treatments for hair loss on the market. However, only Nolopecia targets the latent viruses that cause an increase in 5alpha-R, DHT, and AR observed in people with hair loss and balding.”

Female pattern hair loss is a specific type of hair loss that is common in postmenopausal women. Menopause causes a change in a woman’s hormones, leading to a decrease in estrogen. Estrogen supplementation has been shown to increase hair growth in postmenopausal women.

However, estrogen supplementation has serious side effects, and scientists aren’t sure how exactly it works to increase hair growth. To study the link between estrogen and balding in women, researchers removed the ovaries of female mice, causing the mice to go through menopause and have hair loss [1].

Then they measured the expression of different genes in these mice. The scientists noticed a decrease in the expression of a gene called ANGPT2, which is controlled by the estrogen hormone. The researchers then supplemented the mice with the protein expressed by the ANGPT2 gene.

The results showed hair regrowth after only 24 days.

Interestingly, higher doses of the protein resulted in more hair growth. The researchers concluded that the protein expressed by the ANGPT2 gene can reverse hair loss in postmenopausal mice.

For women who suffer from hair loss and balding, Lilac Corp recommends the natural treatment Nolopecia. The new treatment targets the latent viruses in the body.

This helps the body maintain a normal level of the 5alpha-R, DHT, and AR proteins. A normal level of these proteins stimulates hair growth. There are many treatments for hair loss on the market. However, only Nolopecia targets the latent viruses that cause the increase in 5alpha-R, DHT, and AR observed in people with hair loss and balding.

Lilac Corp is the company that invented the highly effective and unique antiviral natural treatments Gene-Eden-VIR and Novirin.

For more information on these products, see lilaccorp.com.

See also references below.

About Lilac Corp:

Lilac Corp specializes in the development of biology-based patent protected natural treatments. Currently, Lilac Corp is selling four products: Gene-Eden-VIR, Novirin, Nolopecia, and Noacnin. Lilac Corp ships its products to more than 100 countries around the world. What makes Lilac Corp special is that all its products are tested in clinical studies that follow FDA guidelines. To ensure transparency, the results of the clinical studies are published in leading scientific journals. Lilac Corp also offers a 90-day money back guarantee.

Sources:
[1] Endo, Y., Obayashi, Y., Ono, T., Serizawa, T., Murakoshi, M., & Ohyama, M. (2018). Reversal of the hair loss phenotype by modulating the estradiol-ANGPT2 axis in the mouse model of female pattern hair loss. Journal Of Dermatological Science. doi: 10.1016/j.jdermsci.2018.04.001

[2] Polansky H, Javaherian A, Itzkovitz E. Clinical study in genital herpes: natural Gene-Eden-VIR/Novirin versus acyclovir, valacyclovir, and famciclovir. Drug Des Devel Ther. 2016 Aug 29;10:2713-22

[3] Polansky H, Itzkovitz E, Javaherian A. Clinical study of Gene-Eden-VIR/Novirin in genital herpes: suppressive treatment safely decreases the duration of outbreaks in both severe and mild cases. Clin Transl Med. 2016 Dec;5(1):40.

[4] Polansky H, Itzkovitz E, Javaherian A. Human papillomavirus (HPV): systemic treatment with Gene-Eden-VIR/Novirin safely and effectively clears virus. Drug Des Devel Ther. 2017 Mar 3; 11:575-583

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Scientific Advances to Treating Womens Scalp Conditions

Hair Loss and Balding in Women

Nolopecia Balding and Prostate Cancer

Balding and Prostate Cancer: Lilac Corp reviews a study and recommends Nolopecia, a natural treatment for hair loss

All natural hair loss supplement sold by Lilac Corp

Lilac Corp reviews a study that tested a possible link between early hair loss and prostate cancer.

Nolopecia, targets the latent viruses in the body. This helps the body maintain a normal level of the 5alpha-R, DHT, and AR proteins. A normal level of these proteins stimulates hair growth.”

A study showed that men with very early onset balding are more likely to develop aggressive prostate cancer, and at a younger age [1]. Some prostate cancers are more dangerous than others. Prostate cancer and androgenic alopecia, also called male pattern baldness, are both dependent on androgen hormones.

The study surveyed 1,941 men and found that men balding at age 20 years had a 50% higher chance of developing aggressive prostate cancer.

Also, these men were diagnosed with cancer an average of 16 months earlier than non-balding men.

Men balding at age 40 years and older, or non-balding men did not have the increased risk. Research like this is important because it helps to identify groups of men with a higher risk for aggressive cancer.

Men who are at a higher risk can perform regular screening tests for prostate cancer and should be followed up closely with their doctor.

For men (and women), who suffer from hair loss and balding, Lilac Corp recommends the natural treatment Nolopecia. Lilac Corp is the company that invented the highly effective and unique antiviral natural treatments Gene-Eden-VIR and Novirin.

The new treatment, called Nolopecia, targets the latent viruses in the body. This helps the body maintain a normal level of the 5alpha-R, DHT, and AR proteins. A normal level of these proteins stimulates hair growth.

There are many treatments for hair loss on the market.

However, only Nolopecia targets the latent viruses that cause the increase in 5alpha-R, DHT, and AR observed in people with hair loss and balding.

About Lilac Corp:

Lilac Corp specializes in the development of biology-based patent protected natural treatments. Currently, Lilac Corp is selling four products: Gene-Eden-VIR, Novirin, Nolopecia, and Noacnin. Lilac Corp ships its products to more than 100 countries around the world.

What makes Lilac Corp special is that all its products are tested in clinical studies that follow FDA guidelines. To ensure transparency, the results of the clinical studies are published in leading scientific journals. Lilac Corp also offers a 90-day money back guarantee.

Source:
[1] Papa, N., MacInnis, R., English, D., Bolton, D., Davis, I., & Lawrentschuk, N. et al. (2017). Early-onset baldness and the risk of aggressive prostate cancer: findings from a case-control study. Cancer Causes & Control, 29(1), 93-102. doi: 10.1007/s10552-017-0981-0

Source

Improved Minoxidil Formulation Safe, Effective for Androgenetic Alopecia

alopecia market

Alopecia Market: Global Investment Analysis

Alopecia Market: Global Investment Analysis, Size, Challenges, Opportunities and Forecast by 2022

According to the Global Alopecia Market report, the Alopecia Market accounted a value of $8.12 billion in 2015 and is projected to reach a value $12.53 billion at the end of 2022.

The Global Alopecia Market report covers the Alopecia Market in a comprehensive manner, across all parameters such as types, applications, users, top players, and regions.

The report further covers the drivers, restraints and trends in the Alopecia Market for the customer to understand the intricacies of the Alopecia Market which will help them create an efficient plan of action to grow at the fastest rate across the globe.

The Global Alopecia Market is expected to keep rising at a CAGR of 17.6% for the forecast period of 2017 – 2022. The Global Alopecia Market report provides the customer an accurate analysis of the Alopecia Market to assist them in planning their market entry or expansion.

The forecast projection is compiled by a team of subject matter experts and market research professionals to ensure that the information is accurate and presented in an easy to consume tables, charts, and graphs.

For the customer to be able to plan for a significant period, the Global Alopecia Market report covers projections up to 2022.

The current market scenarios and laws under which the market operates in make it easier to understand how the market will play out for the forecast period. The current trends in the market and the drivers and restrains affecting the market might change with the times.

The top players covered in the report include the following:

Lifes2good, Kirkland Signature, Johnson & Johnson., Dr. Reddy’s Laboratories., Cipla., Alpecin., Vitabiotics., Sun Pharma., Phyto Ales Groupe., Phyto Ales Group, and Merck & Co.

Request a Free Sample of The Report: http://www.orbisresearch.com/contacts/request-sample/184998

The report covers a detailed analysis of each majorly impacting player in the Alopecia Market such as the company profile, the latest developments by the player in the Alopecia Market, and the product portfolio of the player currently available in the Alopecia Market, as well as the regions they operate in majorly.

Alopecia Types Covered:
Alopecia Universalis
Alopecia Totalis
Alopecia Areata

Products Covered:
Shampoos and Conditioners
Vitamins and Supplements
Other Products
Gels and Oils
Serums

Treatment Types Covered:
Hair Transplant Services
Low Level Laser Therapy
Oral Treatment
Topical Treatment
Injectable
Plasma Therapy
Steroids
Injectable Fillers
Other Treatment Types

Genders Covered:
Male
Female

End Users Covered:
Homecare Settings
Aesthetic Clinics
Dermatology And Trichology Clinics
Hospitals
Other End Users

The regions covered in the Global Alopecia Market report include North America (US, Canada, Mexico), Europe (Germany, UK, Italy, France, Spain, Rest of Europe), Asia Pacific (Japan, China, India, Australia, New Zealand, South Korea, Rest of Asia Pacific), South America (Argentina, Brazil, Chile, Rest of South America), and Middle East & Africa (Saudi Arabia, UAE, Qatar, South Africa, Rest of Middle East & Africa).

The Global Alopecia Market report covers the SWOT analysis of the Alopecia Market along with key developments in the market that will be helpful for the customer. Anyone with either academic of business interest in the Alopecia Market, the report will definitely by handy.

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Orbis Research (orbisresearch.com) is a single point aid for all your market research requirements. We have vast database of reports from the leading publishers and authors across the globe. We specialize in delivering customized reports as per the requirements of our clients. We have complete information about our publishers and hence are sure about the accuracy of the industries and verticals of their specialization. This helps our clients to map their needs and we produce the perfect required market research study for our clients.

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hair loss supplements

Pediatric Alopecia Areata Severity Linked to Serum Vitamin D

Pediatric Alopecia Areata Severity Linked to Serum Vitamin D

For pediatric patients with alopecia areata, vitamin D is negatively correlated with disease severity, number of patches, and disease duration, according to a study published online in the Journal of Cosmetic Dermatology.

Mehmet Unal, MD, and Gulsum Gonulalan, MD, from the Konya Numune Hospital in Turkey, examined vitamin D status in 20 pediatric patients with alopecia areata and 34 pediatric healthy controls. The authors assessed the correlation between vitamin D status and disease severity, number of patches, and disease duration.

The researchers found that the mean serum 25-hydroxyvitamin D concentration was 15.47±7.66 and 11.09±10.53 ng/mL in patients and controls, respectively; no statistically significant difference was seen between the groups (P =.084).

Significant, negative correlations were seen for vitamin D concentration with the Severity of Alopecia Tool score (P <.001; r, -0.831), number of patches (P <.001; r, -0.989), and disease duration (P <.001 and r, -0.997).

“Vitamin D deficiency is not the only etiologic factor in alopecia areata pathogenesis, but in the presence of other etiological factors, this deficiency can aggravate alopecia areata severity, and thus, vitamin D supplementation may be beneficial in treatment of pediatric alopecia areata,” the authors write.

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alopecia research

Alopecia Treatment Market Significant Profits Estimated to be Generated by 2022

Alopecia (Hair Loss)Treatment Market Significant Profits Estimated to be Generated by 2022

Alopecia is a term used to describe excessive hair damage under certain medical conditions or dietary issues. Sedentary lifestyle, and unhealthy diets is leading to loss of hair among masses.

Furthermore, ageing and hormonal imbalance, increasing chronic disease like arthritis, cancer, hypertension, depression also leads to hair loss especially among middle aged population.

According to American Hair Loss Association, androgenetic alopecia accounts for over 95% of hair loss in men.  Over 800 thousand patients are seeking some kind of treatment for hair loss worldwide.

A sample of this report is available upon request @   https://www.persistencemarketresearch.com/samples/9677

For the treatment of alopecia, U.S. FDA proved two drugs – Minoxidil, to treat hypertension and finasteride (Propecia) to treat benign prostate hyperplasia (BPH). American Hair Loss Association recommends the use of minoxidil in patients who have not responded to finasteride treatment. Prevalence rate of alopecia is high among working age population.

Propecia hair loss

Treatment seeking rate for alopecial is more prevalent in developed regions as compared to that in developing regions, however, over the past few years, demand for alopecia treatment has increased dramatically in developing regions such as China and India owing to increase in healthcare expenditure and improved healthcare infrastructure facilities. In China, 6 percent females and 21 percent of males suffer from hormone driven hair loss.

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.

Alopecia Treatment Market is broadly classified on the basis of the following segments –

Alopecia Treatment Market by Product:

Vitamins and Supplements
Shampoos and Conditioners
Others (Serums, gels and oils)

Alopecia Treatment Market by Gender:

Men
Women
Children

Alopecia Treatment Market by End User:

Homecare Settings
Dermatology Clinics
Others (Salons)

The alopecia treatment market has grown substantially at a healthy CAGR due to changing lifestyle and greater emphasis on outward appearance to look good. With rapid technological advancement and innovation, alopecia treatment market is expected to grow globally.

North America is the largest market for alopecia treatment while Asia Pacific is expected to be the fastest growing market during the forecast period.

The alopecia treatment market is expected to register a significant CAGR during the forecast period. Depending on geographic regions, alopecia treatment is segmented into seven key regions: North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. North America, followed by Europe, is expected to dominate the alopecia treatment market throughout the forecast period.

Asia Pacific excluding Japan is poised to witness fastest growth owing to outburst of middle aged population in the region. Also, the region is witnessing healthy growth in terms of GDP, which in turn is expected to propel growth at healthy digits. Middle East & Africa and Latin America are expected to sluggish growth during the forecast period.

Some of the key market players for alopecia treatment market are Cipla, Viviscal, Dr. Reddy’s Laboratories Ltd., Regaine, Merck & Co., Inc, Ranbaxy Laboratories Ltd, Phyto – Alès Groupe, Kirkland Signature, Vitabiotics, Nanogen, Alpecin – Dr. Kurt Wolff GmbH & Co. KG, Rogaine – Johnson and Johnson.

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