Two days ago, someone named “Xaser94” on the hairlosstalk forums started an extremely interesting thread related to a company named Follica (which I have covered on this blog before).  The main point behind that thread is that PureTech Health (the majority owner of Follica) just released a lengthy and insightful year-end 2015 summary document (125 pages long) of all their subsidiaries on their website.  Also see this alternative summary document here.

Key quotes from that document regarding Follica:

• Follica’s product concept originated from basic science demonstrating new hair follicle formation in adult mice following skin disruption, the results of which were published in Nature.
• Follica’s three clinical studies of patients with androgenetic alopecia demonstrated hair follicle neogenesis via biopsy following skin disruption and/or hair growth through target area hair count.  One of these studies demonstrated that skin disruption alone was safe and generates new follicles as well as new hair, but did not achieve its primary endpoint as the chosen investigational compound (lithium gluconate 8 percent gel) did not further enhance the effect.  A separate clinical study, published by third-party academics, indicated that the combination of skin disruption and an approved hair-growth compound, minoxidil, showed a 4x enhancement versus the efficacy of the compound alone. [My note: Maybe referring to this 2013 study from India?].
• Follica plans to initiate a registration study in the second half of 2016, with data read-out in 2017.
• If the data are favourable, Follica would potentially plan to seek FDA clearance in 2017, with commercial release to follow as soon as 2018.

It should be noted that prior data released by Follica has generally been favorable, so there is a good chance that the new data will also be positive.

Follica Background & Technology

I have discussed Follica a few times on this blog before even though the company was formed in 2006 and I have been skeptical about it going anywhere after a decade of being in the news.  The last time I discussed Follica was in September of last year when the company’s patents were finally approved.  At the time, it seemed like Follica might add FGF-9 into the product mix after the wounding, although this is not as yet a given.  FYI — also, make sure to reread my old post on dermarolling.

The science behind Follica’s technology is very interesting and seems to make logical sense even to a non-scientist such as myself. In the word’s of the main researcher behind Follica’s technology, the renowned Dr. George Cotsarelis:

“When cells move in to close a wound, they are trying to make a decision: Should I make epidermis or should I make a hair? There is a window of opportunity in which we can push them to make hair.”

While over the years I have become dissuaded with both Follica and Dr. Cotsarelis due to numerous delays in their work (along with Dr. Cotsarelis making some pessimistic statements about competing technologies), I have nevertheless continued to be a proponent and follower of this company’s science.  It is extremely hard to create permanent NEW hair follicles in humans.  Numerous scientists have failed to do so over the years when trying to clone or multiply hair follicles in a lab.  Follica’s wounding technology is highly unlikely to cause any serious side effects such as cancer and will most likely be much faster to get government approval in comparison to cloning or multiplication type procedures.

It should be noted that Follica’s technology does not only entail wounding, but also the application of some kind of proprietary compound containing “various drugs and chemicals” once the scalp has been wounded.

And finally, a word from commentator Mike:

Around exactly the same time that I read the original HLT forum new thread on this development, one of this blog’s commentators named Mike also sent me the below pasted insightful e-mail and I should give him credit too:

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Usually post as Mike and would’ve posted this but to be honest, I am sick of myself banging on about Follica but here’s something potentially worthwhile I found here (and I saved the best bit until last):

http://www.londonstockexchange.com/exchange/news/market-news/market-news-detail/PRTC/12767403.html

In the section titled External Validation, Follica received funding in 2015…

During 2015, Gelesis (twice), Tal Medical, Follica, and Karuna all closed financing rounds with external partners, with Akili closing a round post-period end. External financing rounds provide further validation for the technology plus, in the case of equity financings, validation of the business values, as was the case for Gelesis, Akili, and Tal Medical. In July 2015, Karuna received the Wellcome Trust’s Translation Fund Award, comprising a low-interest, unsecured convertible note of up to $3.8 million to fund Karuna’s combination proof-of-concept study, to demonstrate the potential of Karuna’s lead therapy, KarXT.

But they obviously didn’t advertise this. Question is why? I still think they’re up to something (good I hope!)

Now, that’s not the only bit of news. Under the section “Late Stage Pipeline”, look what it says:

Follica is progressing towards its registration study, and is expected to initiate its registration study in the second half of 2016.

I don’t know what that is but it sounds good right? But things are progressing, albeit very very much on the QT.

Perhaps that blog title might need to shave a couple years off it? Maybe too optimistic?? Or because here’s the last little tidbit I found:

Follica has also performed and funded preclinical work which, together with research from the University of Pennsylvania, serve as the foundational observations on which the technology is based. Follica plans to initiate a registration study in the second half of 2016, with data read-out in 2017. If the data are favourable, Follica would potentially plan to seek FDA clearance in 2017, with commercial release to follow as soon as 2018.

It’s under the section, “growth stage businesses”

Who knows but they’re going to an awful lot of trouble to say virtually nothing at all. And they’ve done 3 clinical trials. We only know about one because that’s the only one available to the public. There’s a couple of big ifs there. The data being favorable in particular but they have come this far.

I know you don’t like being emailed but I think this was worth it.

Fingers and toes crossed for 2018!!!!

All the best,

Mike

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