Category Archives: ATI-50002

Aclaris Therapeutics Countdown Begins

As usual my plans to avoid talking about Aclaris for several months went down the tubes yet again (always a good thing). For those who are new to this blog, you can go to the “Categories” menu and select the “Aclaris Therapeutics” choice to read all my prior posts about the company. It is developing a unique topical JAK inhibitor product to treat androgenetic alopecia, the most common type of hair loss.

Aclaris Therapeutics Phase II Trials Commencing

Yesterday, blog reader “Champpy” made a highly interesting lengthy comment about the soon to start Aclaris Therapeutics Phase 2 clinical trials for their topical JAK inhibitor product named ATI-50002 (for treating male pattern hair loss). He was approached by a research company that is recruiting volunteers for the trials. The most important part of his comment was that they are especially interested in patients who are at least Norwood 3, 4, and 5 on the receding hairline scale. This caught my eye, because the implication is that the company expects ATI-50002 (if effective) to regrow hair even on entirely balding regions of the scalp.

Moreover, Aclaris also updated its clinical trials page yesterday with far more details (h/t “Tocatta”). While they mention that they are looking for 24 male and female participants, the research company that approached “Champpy” said that there was major interest from people interested in volunteering. I wonder if they can change their minds and recruit more than 24 people? Or maybe they are recruiting 24 people in each location that they mention on there (Colorado, Oregon and Texas) for a total of 72? The trials are expected to be completed at the end of October 2018.

Having mentioned all the above encouraging and speedy developments, it is still a good idea to keep things in perspective:

  1. There is a possibility that this topical JAK inhibitor treatment can cause serious side effects, including cancer. At the moment, this possibility looks to be rare to nonexistent, but it is too soon to tell for sure. Of course at the slightest sign of cancers or tumor growth, clinical trials will likely be disbanded immediately by the US FDA.
  2. Even on alopecia areata patients who often see tremendous hair regrowth with oral JAK inhibitors (e.g., see here and here), success rates have not been universal. Some patients see no regrowth at all, although at least half seem to get great results. So even if this treatment does end up working on those with androgenetic alopecia, it is likely that some people will never see any benefits.

I have mentioned this a number of times, but it is worth repeating: Aclaris is the first ever company involved in the search for a hair loss cure that has moved along faster than expected. In all other cases that I can remember from the past, companies involved in this sector have moved along far slower than expected, with numerous delays in trials and funding. Oftentimes, these companies have decided not to proceed with final stage clinical trials; or have sold rights to other companies; or have decided not to bring a product to the market even if it is somewhat effective at regrowing hair.

Hopefully Aclaris keeps surprising us and goes All The Way in this year of Shohei Ohtani.

Also, in March and April 2018, Aclaris CEO Neal Walker purchased almost 20,000 of his company’s shares.

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.