FOL-005, Follica, Follicum

Follicum, Follica and French Fries in February

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Follicum

I am on Follicum’s mailing list and the company had four significant developments during the past month that were deemed worthy of e-mailing to subscribers:

  • On January 18th, Follicum announced the identification of key receptors in human hair follicle cells to which the company’s lead hair loss candidate (FOL-005) binds. FOL-005 is a modified version of the endogenous protein, osteopontin.
  • On February 2nd, Follicum announced the launch of its English language website. It is worth going through the menu titled “Hair Growth”. The Swedish version of the site remains online.
  • On February 6th, Follicum CEO Jan Alenfall gave an interesting interview to Aktiespararna. He discusses both the hair loss product as well as the new diabetes product FOL-014.
  • Of most important to us, on February 7th, Follicum announced that it had received go-ahead approval from the German Medicines Agency (BfArM) and German Ethics Committee. This is to commence a Phase IIa clinical trial in Germany in relation to FOL-005 on human patients. The company will partner with Clinical Research Center for Hair and Skin Science (CRC) in Berlin and bioskin in Hamburg.

Follica

In 2016, Follica announced that it was going to address its hair loss treatment via the acronym “RAIN”. At the time, I guessed the “R” to mean Regeneration, and the “N” to mean Neogenesis. Earlier this month, blog reader “PinotQ” notified us that Follica owner Puretech most likely recently updated its website and now spells out that the “AIN” stands for Abrasion Induced Neogenesis. Perhaps we just missed this development last year, but it is important enough to spell out here.

French Fries

A few days after I covered the groundbreaking work of Dr. Junji Fukuda, major newspapers around the world figured out a different (i.e., clickbait) take on the story. One that clearly got far more publicity and Facebook likes. They labeled Dr. Fukuda’s discovery as “Chemical in McDonald’s French Fries Could Cure Hair Loss” plus other minor variations of that title.

All because the chemical (dimethylpolysiloxane) used in the McDonald’s french fries via the oil fryers was involved in part of Dr. Fukuda’s research, even though it had no direct influence on hair regrowth. This french fries fable has since became the biggest hair loss related story of the year, and is unlikely to be surpassed in superficial importance for the rest of this year.

McDonald's French Fries Hair Loss
McDonald’s french fries 12-month upward search trend due to hair loss cure story.

Unbelievably, numerous blog readers who already read my original post on this research still thought that the McDonald’s fries story was something totally different and perhaps worth looking into.

I had to delete the repetitive reader comments about this subject in recent posts and did not bother to respond to any e-mails abut this story.

The best advice comes from Dr. Fukuda himself:

“I have seen online comments asking, ‘how many fries would I have to eat to grow my hair?’” he said. “I’d feel bad if people think eating something would do that!”

Other Items of Interest

— Some new companies and increasing competition in the South Korean over-the-counter hair loss treatment market.

— Replicel gets new investment from Chinese company YOFOTO. Seems like the hair loss product related treatment rights were not granted, probably due to Replicel’s binding agreements with Shiseido regarding the Asia region?

— Since JAK inhibitors have been working on many alopecia areata and vitiligo patients, I have followed both conditions more closely in recent years. Here is an interesting alternative story about a vitiligo patient.

Aclaris Therapeutics, ATI-50002, Topical JAK Inhibitor

Aclaris Expecting Phase 2 Data on AGA by mid-2019

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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.