Aclaris Expecting Phase 2 Clinical Trial Data on AGA by mid-2019

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.

2018 AAD Annual Meeting

The field of dermatology is quite vast and encompasses diseases and conditions of the nails, hair (both body and head), scalp and skin. Nevertheless, at the annual meetings of all the major dermatological organizations around the world, there are always many interesting presentations related to the head hair that most concerns us.

The American Academy of Dermatology (AAD) was founded in 1938 and currently counts virtually all practicing dermatologists in the United States as members. I wrote a post on the 2016 AAD annual meeting, but did not do so in 2017 (when instead I covered the annual meeting of SID). Interestingly, SID was founded in 1937, just one year before AAD.

This year’s upcoming 2018 AAD annual meeting will be hosted in San Diego and run from February 16-20. See program overview here. A detailed pdf of all the presentations can be found here. Below are some of the interesting things that I noticed after a cursory glance through the program:

  • I was very surprised to see so many renowned hair loss researchers disclosing their affiliation with Aclaris Therapeutics (probably via research finding or grants). I am hoping that at least several of these researchers are testing JAK inhibitors on androgenetic alopecia patients for Aclaris and not just testing them on alopecia areata patients. According to this page, among the researchers disclosing an affiliation with Aclaris include: 1) Dr. Elise Olsen; 2) Dr. Jerry Shapiro; 3) Dr. Rodney Sinclair; 4) Dr. Antonella Tosti;  and 5) Dr. Ken Washenik. The latter three of these are affiliated with an unbelievable number of companies that are working on a hair loss cure or treatment. Dr. Washenik’s presentation is titled: “Emerging treatments of androgenetic alopecia” and I would not be surprised in the least if he made a presentation by the exact same title 20 years ago (alongside the also ancient Dr. George Cotsarelis).
  • A significant number of presentations entail hair loss, hair disorders, hair care and hair styling in African Americans and other people of color, especially women. One of the presentation abstracts even suggests that hair loss in African American women is under-reported, under researched and currently an epidemic.
  • Related to the above, a majority of the hair related presentations seem to be led by women. Earlier conference presentations were dominated by men, but this has been changing rapidly in recent years as I have mentioned several times on this blog in the past. I guess men have been taking too long to bring about a hair loss cure, and, in the words of Mr. Bannon: “The anti-patriarchy movement is going to undo ten thousand years of recorded history“. Hopefully he meant recorded history on wars and on the search for a hair loss cure.
  • The highly regarded researcher Dr. Rox Anderson (covered here) is presenting on low-level laser therapy (LLLT) and hair growth alongside Dr. Maria Hordinsky and Dr. Ronda Farah. I have neglected LLLT (photobiomodulation) during the past year, but am glad to see that Dr. Anderson is still a believer in the technology. Usually, companies or people who are selling laser devices are the biggest proponents of LLLT, leaving much room for skepticism.

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