Category Archives: ATI-50002

An Overdue Aclaris Update

Update: February 29, 2020

Aclaris Exits Hair Loss Business

Recent rumors are, unfortunately, very true. Several days ago, I contacted Aclaris Therapeutics’ Head of Corporate Strategy Mr. Michael Tung. I asked him for any update on their androgenetic alopecia (AGA) JAK inhibitor product. His short and succinct response was as follows:

“We exited all of that unfort”.

I am disappointed, but was expecting this bad news. Their pipeline page no longer even shows any products to target AGA or Alopecia Areata (AA). Last year, they were searching for a partner to help further develop their “investigational compounds” ATI-501 (oral) and ATI-502 (topical).

Sorry to reader “nasa_rs”. However, not a big surprise after the past year of limited information releases by Aclaris regarding their alopecia products.

March 18, 2019

Aclaris JAK Inhibitor Trial Update

I used to cover Aclaris Therapeutics and its topical JAK inhibitor product for androgenetic alopecia fairly regularly. However, there have been very few significant recent updates.

Today morning, Aclaris released a summary of its FY 2018 results. The most relevant part for us concerns the ATI-502 topical Janus Kinase (JAK) 1/3 inhibitor product for AGA. They also seem to name this same product as AGA-201 and ATI-50002 in other references.

Per the latest news, Phase 2 open-label clinical trials for ATI-502 (a topical JAK1/3 inhibitor) involve 31 patients with AGA. Interim 6-month data are expected in the second quarter of 2019, while comprehensive 12-month data will be realized in the second half of 2019.

So by the end of this year, we should finally have at least some idea on whether JAK inhibitors can at least somewhat help patients with AGA (aka male pattern hair loss).

The trials will measure both safety and efficacy.

We already know beyond a doubt that JAK inhibitors significantly help people with the less common alopecia areata. As well as thos with its various related forms (alopecia totalis and alopecia universalis).

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.