Category Archives: JAK Inhibitors

Aclaris Announces Positive 6-Month Results for Androgenetic Alopecia

Update: Dr. Neal Walker interview.

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 in 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”.

Aclaris to Initiate Phase 2 Trials for JAK Inhibitors for AGA in First Half of 2018

Every time when I feel like my discussion about Aclaris Therapeutics and their soft topical JAK inhibitors for treating androgenetic alopecia (AGA) is finally done for at least 3 months, some new surprise comes up. I say “surprise” because the company has not even as yet commenced Phase 1 clinical trials for their AGA product (see pipeline), so regular unique updates are always unexpected.

This week I got several emails from Aclaris, and they mentioned their continued work and plans for the topical JAK product to treat AGA. Nothing much new in there. However, earlier today, my google alerts for Aclaris gave me a link to this new informative eight page interview with the CEO Dr. Neal Walker and various others. How does “Seeking Alpha” get these interviews before other sites?

In any case, I had to re-register with the above site in order to see the whole interview (which can be set to show up on one page instead of on eight pages). A key quote from the chief scientific officer Dr. Stuart Shanler clearly stood out and necessitated my writing this post:

“We also intend to initiate a Phase 2 open-label trial with ATI-50002 in AGA that is androgenetic alopecia in the first half of 2018.”

If this really does happen as scheduled, it would be superb news. However:

  1. I am a bit confused about why their topical AGA product in their pipeline is not labeled as ATI-50002, even though the above quote implies as such. It is also worth remembering that just two months ago, Aclaris was granted several patents that implied that a number of different JAK inhibitors (“-tinibs”) could help male pattern hair loss sufferers. So in the end they might perhaps come out with several different topical products for AGA rather than just one.
  2. It would be useful to know how they can skip Phase 1 clinical trials since their pipeline still shows those as not having even commenced as of today. As many have postulated in the past, since some of these topical JAK inhibitors have already been tested for other uses and by other entities such as Confluence and Columbia University, perhaps Phase 1 trials can be skipped or sped up?
  3. They plan to conduct open-label trials, which can be a bit biased it seems.

In any event, unless the interview with Mr. Walker et al. was transcribed incorrectly, this is a big development and the first half 2018 Phase 2 trials goal comes right from the horse’s mouth.

H/T to Malcolm for pushing me to write this post today.