Category Archives: JAK Inhibitors

Aclaris to Initiate Phase 2 Trials for JAK Inhibitors for AGA in 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.

Aclaris Granted two Patents for JAK Inhibitors and Hair Loss Disorders

Aclaris Therapeutics’ latest e-mail from today morning contained a link to the following press release:

Aclaris Therapeutics Announces Issuance of Two U.S. Patents Covering JAK Inhibitors for Treating Hair Loss Disorders

Quite often, when Aclaris discusses hair loss disorders in its press releases, they only mention alopecia areata (an autoimmune disorder that is responsible for hair loss in 2 percent or so of hair loss sufferers). However, this time they specifically mention androgenetic alopeia (AGA) six different times in their press release so it was worth writing a post on this development. Around 98 percent all men who suffer from hair loss suffer from AGA.

If you are new to this subject matter, make sure to read all the past posts on this blog regarding Aclaris.

Aclaris’ Latest Patents

The two patents that were just granted to Aclaris are highly detailed and informative:

Patent Number 9,737,469 — covers the use of tofacitinib, baricitinib, ruxolitinib and decernotinib, specifically for treating androgenetic alopecia.

Patent Number 9,730,877 — covers the use of baricitinib for inducing hair growth and for treating hair loss disorders such as alopecia areata and androgenetic alopecia.

If you have time, I would encourage you to go through all the “US Patent Document” links in the upper part of the above two patent pages. Those reference documents go all the way from 1998 through 2016. If I had more time, I would search for “androgen” in all those documents and see what comes up.