Category Archives: Aclaris Therapeutics

Aclaris Therapeutics, ATI-50002, Topical JAK Inhibitor

Aclaris Expecting Phase 2 Data on AGA by mid-2019

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Every time I hope not to write about Aclaris for at least two months, I get disappointed. A very welcome disappointment of course. While this trend has been going on for two years, the past three months (including the latest development from yesterday) are worth summarizing below:

  • In November of 2017, I wrote about how Aclaris planned to start Phase 2 clinical trials in 2018 for its topical JAK inhibitor product to treat androgenetic alopecia (AGA). This was a major and pleasant surprise since the company had not even started Phase 1 trials at the time of writing. I am guessing that Aclaris can skip Phase 1 trials since they and many others have already tested oral and topical JAK inhibitors for other uses such as treating alopecia areata and vitiligo. To this day, Aclaris’ product pipeline page still lists its topical “soft” JAK inhibitor program for treating AGA to be in a pre-clinical stage of development. Very strange, and probably just a delay in updating their website.
  • A few days ago, I discovered that a surprising number of renowned hair loss researchers presenting at this week’s American Academy of Dermatology Conference were now suddenly declaring an affiliation (probably research funding related) with Aclaris. I wrote about this in my last post. It would be very unusual if at least several of these researchers were not testing topical JAK inhibitors on humans for androgenetic alopecia on behalf of Aclaris.
  • And finally, yesterday Aclaris made an important investor presentation in which it announced that in the first half of 2019 it was expecting results from its Phase II clinical trials for treating AGA with its topical JAK inhibitor product named ATI-50002. You can access the audio as well as the slides for this presentation via this page (make sure to look under past events for the LEERINK Partners event). On page 47 of the slides you can see the above details (h/t Malcolm and Royaume).
  • On a side note, Aclaris CEO Neal Walker just updated his blog. Something he does fairly infrequently,
  • And it is worth keeping a track of Aclaris’ first ever FDA approved product called Eskata (to treat a skin condition called seborrheic keratosis) that was released at the end of last year. The success or failure of this hydrogen peroxide based topical product will give some indication of how reliable the company is as well as how likely it is to succeed financially this year. The NY Times recently had an interesting article on Eskata titled: “Have We Aged Out of Age Spots?“. Note that Aclaris is for the first time presenting Phase 3 clinical trial data on Eskata at this week’s annual AAD conference. So they started selling this product even before presenting Phase 3 trial results anywhere it seems?

Until late last year, I was not even optimistic that Aclaris would complete Phase 1 trials for AGA this year. Now it looks like they might have already commenced Phase 2 trials in 2018 and we can look forward to seeing the final data by mid-2019 at the latest. Judging by the speed with which this company is moving along, if Phase 2 results are favorable, I would not be surprised if Phase 3 trials get completed before the end of 2020.

Aclaris Therapeutics, JAK Inhibitors

Aclaris Phase 2 Trials for JAK Inhibitors for AGA

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Every time when I feel like I am done covering Aclaris Therapeutics and the company’s topical JAK inhibitors for treating androgenetic alopecia (AGA) for a few months, some new surprise comes up. The company has not even as yet commenced Phase 1 clinical trials for its AGA product. Yet we keep getting interesting new updates on a regular basis.

Aclaris JAK Inhibitor Alopecia Areata Before and After Photo

Aclaris Therapeutics: Phase 2 Trials for JAK Inhibitors for AGA

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. Moroever, the first half 2018 Phase 2 trial initiation goal comes right from the horse’s mouth.

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