Category Archives: Aclaris Therapeutics

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.

Brief Items of Interest, December 2017

There were way too many developments in the past month, at least half of which probably deserved their own post.

Wounding, Interleukin-1 (IL-1) and γδ T-cells

Wounding led hair growth has been in the news a lot in the past several years.

At the end of 2013, I first discussed Dr. Krzysztof Kobielak and Dr. Eve Kandyba from USC in relation to their work on how the Wnt7 gene activates hair growth. Fast forward to this month, and both scientists are back in the news and (via a collaboration with researchers from UC San Diego and from India) published an important paper titled: “Stimulation of hair follicle stem cell proliferation through an IL-1 dependent activation of γδT-cells“. Interestingly, one of the three most important words used throughout the paper and of primary importance to us (“wounding” or “wound“) is missing from the above title, although not from the complementing photo (see red area in the image further below).

These scientists found that wounding triggers interleukin-1 (IL-1), which in turn activates certain immune cells (called γδT-cells or gamma delta cells). These immune cells then awaken resting stem cells in the hair follicle so that they can then “multiply and travel to the wound site to repair the injury”. For our purposes, the hair follicle stem cell activation is more important than any kind of wound repair (i.e., hair > scar improvement).

Commentator “Omg” who has posted some great material in recent weeks (including the above — thanks) wrote that this finding is the biggest discovery of the past decade. I am not so sure. Note that the authors of this latest work are not affiliated with Follica (the widely discussed company that is developing a “wounding + favorable compound injection” related procedure to regrow hair); nor are they affiliated with Dr. Rachita Dhurat, who has published several groundbreaking papers related to wounding and hair growth. Makes this discovery from an entirely different group all the more exciting, and further validates the potential of wounding spurred hair regrowth.

Interleukin-1 and hair growth

Nanogel Encapsulated Dermal Papilla 3D Spheroids and Hair Follicle Regeneration

In 2015 I interviewed Dr. Malcolm Xing from Canada. In 2016, I discussed the same doctor’s new findings related to a novel improved “hanging drop” 3D cell culturing technique for the purpose of hair growth. Dr. Xing has constantly been trying to improve upon the renowned Dr. Colin Jahoda’s work.

This month, Dr. Xing and a team from China have published a new paper titled “Bottom-up Nanoencapsulation from Single Cells to Tunable and Scalable Cellular Spheroids for Hair Follicle Regeneration“. I am not motivated enough to try to make the sci-hub site work (I get mixed luck with that) to gain free access to this whole paper, since I do not want to then spend hours trying to understand the complicated science behind this research. I am, however, in no doubt whatsoever that any new development related to 3D spheroids and hair culturing is of utmost importance and warrants coverage on this blog.

More Good News from Aclaris

In November, I discovered an interview in which Aclaris Therapeutics’ chief scientific officer mentioned that in the  first half of 2018, Aclaris planned to commence phase 2 trials to treat androgenetic alopecia (male pattern hair loss) with topical JAK inhibitors. This was a huge development, since we are used to virtually all companies in the hair loss world postponing or delaying clinical trials. In contrast, Aclaris is doing the opposite and moving to phase 2 trials without even having done phase 1 trials! They probably got to skip phase 1 trials because they have tested the same JAK inhibitors (including oral and topical versions) for other conditions.

Several weeks after I posted the above pleasing development, Aclaris announced at an investor conference that they would start the above trials at the end of the first quarter of next year (i.e, end of March 2018). Yet again they surprise us with their speed, and do not want to wait will June 2018. The announcement can be accessed by going to their website and finding their latest investor conference presentations (often available in both audio and slide formats).

Thanks to “Royaume” who listened to the whole audio for us (albeit misinterpreted its favorable implication). Commentator “Malcolm” even felt like I should have devoted a whole post to this news, but I did not want to do so less than a month after my prior post on Aclaris. Moreover, past experiences make me think that Aclaris will delay its trial commencement target dates (like all other companies seem to do), although I hope I am wrong.

Follicum also Plans Phase 2 Trials in Early 2018

Even though Follicum has been present in the hair loss world well before Aclaris even commenced operations, the former has not moved along as fast as the latter. However, recently Follicum announced that they were planning to start phase 2 trials for their FOL-005 product in early 2018 in Germany.

Replicel CEO Update

Replicel’s CEO was interviewed by “Investing News” towards the end of last month. Key quote:

“There’s a possibility… that [our] hair products could have an early launch in Japan. Our partner Shiseido is funding a clinical trial in Japan that’s expected to release clinical data next year. It’s entirely up to Shiseido what they do in regards to this product. There’s certainly a possibility that they could decide if the data is positive, to launch the product in Japan and that would trigger… milestone payments and sales royalty revenue”.

Other Items of Interest

— I saw a number of comments and received several e-mails regarding the Brotzu lotion. It seems like they updated their EU patent page and several Italian hair loss forum members are claiming that the product is coming out in early 2018. For the time being I will refrain from writing a post on this, as it seems like there is a lot of speculation going on.

— A great thread with before and after photos on Reddit about the power of  the “Big 3” treatment of Finasteride plus Minoxidil plus Nizoral when effective.

PolarityTE starts using its SkinTE product on humans. No info yet on potential hair growth effects on the scalp, but still great to see usage in humans rather than mice so early in the process. Key quote:

“We are confident and believe that SkinTE will replicate its preclinical success and help patients regenerate their own full-thickness, hair-bearing skin”.