Category Archives: Aclaris Therapeutics

Aclaris Therapeutics, Confluence Life Sciences, Neal Walker, Soft JAK Inhibitors

Aclaris Therapeutics and Dr. Neal Walker Update

76 Comments

Aclaris Therapeutics has been in the news a lot so far this month. The company has gone overboard with press releases and e-mail alerts (if you are subscribed) during the first two weeks of August. When I read all their recent press releases, I saw very little in the way of their topical JAK inhibitor program for male pattern hair loss, although one reader e-mailed me about one particular sentence in this press release in which they state that they will:

“Continue to develop another series of topical JAK inhibitors for the treatment of androgenetic alopecia (AGA)”.

Also of major interest is their recent purchase of Confluence Life Sciences.

However, something else extremely significant that I totally missed (despite my weekly Google Alerts about the company) was sent to me by a blog reader yesterday. It is a 10-page Seeking Alpha earnings call/interview with Aclaris CEO Neal Walker and others (can only be viewed in its entirety after registration). There are numerous interesting points in those 10 pages, but by far the most important for our purposes are the below two quotes from the CEO:

Mr. Walker: “We view the soft JAK as applicable to things like male-female pattern baldness”.

Shorty thereafter…

Mr Lugo: “Understood. What’s the timing for the soft JAK program entering the clinic? I’m not sure I heard that”.

Mr. Walker: “We will be giving a more full guidance on that at our Investor Day. We’re looking at approximately 2 years for some of our pipeline assets“.

My Thoughts

  • It seems like they are classifying “topical covalently bound JAK inhibitors” as “soft JAK inhibitors”.
  • Their collaboration and subsequent takeover of Confluence Life Sciences involves soft JAK inhibitor technology among other things. Mr. Walker points out elsewhere in the interview that their original reason for collaboration with Confluence entailed the latter’s soft JAK inhibitor technology.
  • I presume that Mr. Lugo’s comment about “entering the clinic” means being in use at clinics. It seems very hard to imagine that this can happen in two years as Mr. Walker seems to imply. Aclaris’ pipeline currently has both its hair loss related topical JAK inhibitors in pre-clinical trials. The only way they could get these to the clinic in two years is if somehow the US FDA has significantly less stringent regulations for topical versions of drugs relative to oral versions of the same drugs (especially if the oral version has already been approved or is in final phase 3 trials in two years).

So the JAK hope-train continues even if commentator “nasa_rs” is missing lately:-)

Aclaris Therapeutics, Decernotinib, Selective JAK3 Inhibitor

Decernotinib

184 Comments

I have covered janus kinase inhibitors (JAK) in numerous posts on this blog in the past. They were by far the biggest news story in the hair loss world in 2014 due to several groundbreaking studies that showed that using oral JAK inhibitors ruxolitinib or tocafitinib cured alopecia areata (AA), psoriasis and vitiligo in many patients. However, less than 5 percent of hair loss sufferers have alopecia areata (an autoimmune disease), with the vast majority having androgenetic alopecia (AGA) instead.

At the time, the famous hair loss researcher Dr. Angela Christiano maintained that JAK inhibitors could also work on AGA. This statement was later expanded and it was postulated that only “selective topical covalently bound JAK 3 inhibitors” could work, while oral ones would probably not work.

Moreover, of the two main currently FDA approved JAK inhibitors: 1) ruxolitinib only inhibits JAK 1 and JAK 2; and 2) while tofacitinib inhibits both JAK 1 and JAK 3, some suggest that its impact on JAK 3 is not very significant (or especially “selective”).

Aclaris Therapeutics to Test Decernotinib on AGA Patients

Today morning, I got a press release e-mail from Aclaris (which holds all the patents for JAK inhibitors and hair loss disorders) linking to an article titled: “Aclaris Therapeutics Announces Notice of Allowance for Two U.S. Patent Applications Covering Baricitnib and Decernotinib, Respectively, for Hair Loss Disorders“.

Several readers also posted other links about this news or e-mailed me, and of course some mentioned “nasa_rs”, a former NASA employee who comments on this blog all the time. If I had to summarize, most of “nasa_rs”‘ comments are in the form of “JAK inhibitors will cure hair loss or its all over.” But once in a while he also posts something extremely unique and useful.

The most interesting part of Aclaris’ press release is that they finally named the selective JAK 3 inhibitor that they will probably use to test on AGA patients when they start clinical trials. This particular JAK inhibitor is called decernotinib (VX-509), and it is a highly selective JAK 3 inhibitor. In Aclaris’ latest press release, the below pasted sentence is the key one (with the “respectively” implying the AA–>baricitinib and AGA–>decenotinib relationships):

The claims of these newly allowed patent applications cover methods of inducing hair growth and treating various hair loss disorders, including alopecia areata and androgenetic alopecia, by administering baricitinib or decernotinib, respectively.

Interestingly, decernotinib has no separate wikipedia entry at present (unlike most of the other “-tinibs” out there). The wikipedia entry on JAK inhibitors lists all the FDA approved JAK inhibitors that we have discussed as well as numerous others currently in clinical trials.