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.