Aclaris Announces Positive 6-Month Results for Androgenetic Alopecia

Note: Some great photos are in their investor presentation from today. Pasting a couple below after getting permission.

Aclaris JAK Inhibitor Before After Male
Aclaris topical JAK inhibitor before and after photo in a great responder.

Aclaris Topical JAK Inhibitor Works for AGA

Huge news from Aclaris Therapeutics. They have just announced that their much anticipated topical Janus Kinase (JAK) inhibitor product (ATI-502) gave positive hair growth results in patients with androgenetic alopecia (AGA).

The results are for their interim 6-month Phase 2 open-label clinical trials of ATI-502 (also called AGA-201) in humans. 22 males and females participated in the trials till completion, including hair growth measurements. They applied ATI-502 to their scalp twice daily for 26 weeks.

Investigators rated 73% of subjects (16/22) as experiencing increased hair growth, and a higher 82% of subjects thought they saw increased hair growth through self-assessment.

Topical JAK Inhibitor Hair Growth
Modest hair growth after topical JAK inhibitor application for 6 months.

For a long time, many people did not believe that JAK inhibitors could result in hair growth in patients with androgenetic alopecia (i.e., male pattern hair loss). All the results in humans to date had only shown efficacy in patients with alopecia areata (AA), an inflammatory rather than hormonal condition.

Aclaris JAK Inhibitor Trials to Continue

I may add more to this post later, but for now the most significant quotes:

“The overall change was an increase of 8.6 hairs/cm2. Target area hair count increase was 15.3 hairs/cm2 in female subjects and 5.6 hairs/cm2 in male subjects.”

Per Aclaris CEO Dr. Neal Walker:

“This finding demonstrates that inhibiting a non-hormonal and inflammatory-mediated pathway may be an option for the treatment of AGA.”

“Through recent formulation work, Aclaris can achieve significantly higher topical concentrations of ATI-502.”

There was one “unrelated” case of breast cancer among the trial patients, but no-one else had any adverse side effects. I am sure everyone will look into detail at the side effect rates when 12-month trials are completed.

In the first half of 2020, Aclaris plans to initiate a double-blind, randomized, controlled Phase 2 dose-ranging clinical trial with higher concentrations of ATI-502. “With potentially, a female focus.” I hope that just means more females than males, and not just “only” females.

I do not think that this will be a cure for male and female pattern hair loss by any means. Perhaps a highly effective treatment in some patients. Moreover, for those of us who have major itching associated with our hair loss, perhaps we also have an inflammatory component to our hair loss as I have postulated in the past. Maybe the itchiest patients will see the best results?

Worth checking out ACRS stock price movement today.

Congratulations to the biggest JAK inhibitors for AGA fan of them all: blog reader “nasa_rs”.

Dr. Dhaval Bhanusali will Answer your Questions

This morning, Follica announced positive interim data in its Phase II clinical trials. They are now on track to start pivotal trials at the end of 2019, which I discussed a month ago. In this latest press release, they have some interesting quotes from Dr. Ken Washenik and Dr. Rox Anderson.

Dr. Dhaval Bhanusali
Dr. Dhaval Bhanusali: Follica Clinical Adviser.

One of Follica’s well known clinical advisers, Dr. Dhaval Bhanusali, has kindly agreed to answer reader questions! We have been going back and forth about this for a few weeks, but it seems he is now ready after this latest news has become official. I think that this is the first time that I have had success with anyone important on Follica’s team responding in person.

Readers on this blog have at various times posted links to Dr. Bhanusali’s Instagram and Twitter accounts.

Dr. Bhanusali told me the following:

“There are lots of things I can’t say because of NDAs and also legally because companies like Follica have investment partners that are publicly traded (so legally, not allowed to, even if I want to). But happy to talk in generalities at some point and genuine thoughts on things!

I haven’t kept up as much as I should have on hairloss websites, but I think the internet is unfortunately full of companies that take advantage of patients/consumers with false claims and it is super sad. Happy to help if you think I can educate on things that help patients long term.”

So please keep the above in mind when asking your questions in the comments to this post.

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