FOL-005, Follicum

Follicum Phase 2 Trials Update

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Sometimes, news items concerning major developments in the hair loss cure world suddenly bombard us like an incessant rainfall. This is certainly the case so far this month. Always a great feeling to get this type of drenching, but very time consuming. Earlier today, reader “Camaro” notified us that Sweden based Follicum’s latest investor presentation from the BioStock conference was already available on YouTube. See bottom of this post.

Although I just wrote a post earlier today, I decided to add this short one too since this Follicum CEO video presentation is worth a watch. I have covered this company and its FOL-005 hair loss product many times on this blog in the past. My February post that discussed Follicum is worth a reread. Currently, FOL-005 is in Phase IIA clinical trials (in early March they announced that the first patient in these trials was just treated).

Once you click on the link, the below video will start right after company CEO Jan Alenfall arrives on stage. Some very interesting slides in the presentation, including one with the implication that, at best, this product will work slightly better than topical Minoxidil. Such an upfront declaration makes me trust the company more. Note that oral Minoxidil works better than the topical.

The biggest news is that they are seeing a very high 75 percent successful response rate in initial results (Edit: Might have been referring to earlier trial results). They are testing out powder, cream and gel based topical formulations of FOL-005 in order to compound the best possible final topical product.

I am on Follicum’s mailing list and will add a link to the slides on here if they happen to send one.

Aclaris Therapeutics, ATI-50002

Aclaris Therapeutics Countdown Begins

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As usual my plans to avoid talking about Aclaris Therapeutics for several months went down the tubes yet again. This company is developing a unique topical JAK inhibitor product to treat alopecia areata as well as 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, 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.