Category Archives: PureTech Health

Follica Goes Into Hibernation

Follica George Cotsarelis

A few readers have recently mentioned that Follica’s homepage has gone dark. It now only displays a logo and contact e-mail. You can go through my Follica category section to see the numerous times that I covered this company in the past. Unfortunately, as was the case with Histogen, Replicel and Samumed, a decade of coverage has come to naught.

Follica Logo

Note that Follica was founded all the way back in 2005. In 2019, they finally seemed close to beginning Phase 3 trials for their wounding (aka microneedling) device. With the addition of Minoxidil and other proprietary compounds into the wounded scalp skin. Even as recently as 2022, the company’s CEO Jason Bhardwaj sounded very optimistic.

The following quote (credited to Dr. George Cotsarelis) from the old Follica website was very motivating. It meant an almost natural hair regrowth treatment that would likely face few regulatory hurdles from the US FDA:

“Following skin disruption, cells that migrate to help healing are forced to make a decision: Should I make epidermis, or should I make a hair? There is a window of opportunity in which we can potentially push them to choose the latter, and we believe there are multiple biological pathways to target to enhance this outcome. This regenerative effect is called hair follicle neogenesis.”

Follica’s technology is based on work originating from the University of Pennsylvania (led by Dr. Cotsarelis) that has been further developed by Follica’s internal research team.

Follica Goes Into Hibernation

I was not planning to write this post until a reader e-mailed me a recently uploaded 2022 Annual Report from PureTech Health (majority owner of Follica). In there are some interesting statements, the most relevant of which is as follows:

“With an increased focus on resource allocation towards our Wholly Owned Programs, we decided to hibernate the Follica Founded Entity in the 2023 post-period. We may choose to advance this program at a later date or with partners.”

  • PureTech owns 85.4% of Follica.

Note that other companies such as OrganTech and Follicum have recently come back from the dead for second attempts. I feel like Follica will likely come back, although perhaps in a country with more favorable regulations than the US (see below)?

Cumbersome US Regulatory Process to Blame?

The above mentioned Annual Report breaks out in detail the numerous challenges that PureTech/Follica faced with the US government regulatory process. The two main issues seem to pertain to:

  1. Getting separate approvals for a drug versus a device. And from various distinct segments of the FDA.
  2. Complex rule differences governing “wholly-owned” versus “founded” entities. Follica is 85.4% owned by PureTech (after several increases in the stake over the years).

It does seem strange that PureTech is mentioning these issues so late in the game. Especially since they could have tried to bring their device to market with just topical Minoxidil (already FDA approved). I am assuming their proprietary drug contained more than just Minoxidil (a debate we had for many years on this site).

Below, I am pasting the entire statement from page 183 of their 2022 Annual Report:

“The complexity of a combination therapeutic that includes a drug or biologic and a medical device presents additional, unique development and regulatory challenges, which may adversely impact our or our Founded Entities’ development plans. And our or our Founded Entities’ ability to obtain regulatory clearance, authorization or approval of our Wholly Owned Programs or our Founded Entities’ therapeutic candidates.

We or our Founded Entities, such as Follica, may decide to pursue marketing authorization of a combination therapeutic. A combination therapeutic may include, amongst other possibilities, any investigational drug, device, or biologic packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biologic where both are required to achieve the intended use, indication, or effect.

Developing and obtaining regulatory clearance, authorization or approval for combination therapeutics pose unique challenges because they involve components that are regulated by the FDA under different types of regulatory requirements, and by different FDA centers. As a result, such therapeutics raise regulatory, policy and review management challenges.

For example, because divisions from both FDA’s Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research and FDA’s Center for Devices and Radiological Health must review submissions concerning therapeutic candidates that are combination therapeutics comprised of drug or biologics and devices, respectively, the regulatory review and clearance, authorization or approval process for these therapeutics may be lengthened.

In addition, differences in regulatory pathways for each component of a combination therapeutic can impact the regulatory processes for all aspects of therapeutic development and management, including clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, user fees and post-clearance, authorization or approval modifications.

Similarly, if applicable, the device components of a combination therapeutic candidate will require any necessary clearances, certifications or approvals or other marketing authorizations in other jurisdictions, which may prove challenging to obtain.”

Follica Pivotal Trial in 2019, Phase 3 in 2020

Update: June  4, 2020

Follica Phase 3 Trials Scheduled for 2020

Follica (PureTech) just announced that it received positive feedback from a recent “end of phase two” meeting with the US FDA. h/t reader “Pier”. The company is now preparing to advance its lead FOL-004 androgenetic alopecia drug candidate into Phase 3 trials later in 2020. Official announcement by PureTech.

Approximately 280 patients with male pattern hair loss will be enrolled in the final Phase 3 clinical trials. Treatment efficacy will be assessed against two co-primary endpoints: visible (non-vellus) hair count; and patient self-reported outcomes on a pre-established scale. The randomized, controlled and double-blinded studies will be conducted across multiple centers in the US. A maximal use study to understand treatment pharmacokinetics will also be conducted in tandem.

Update: December 19, 2019 — Follica just announced positive topline data from its latest clinical study for androgenetic alopecia. There was a significant 44% improvement over baseline in visible (non-vellus) hair count totals after 3 months of treatment. The final Phase 3 study is expected to commence in the first half of 2020. Quotes from Jason Bhardwaj and Ken Washenik in there.

They did not mention which topical drug was used. However, I would not be surprised if it is just Minoxidil, based on the further below mentioned findings from last month. Hopefully, once the treatment is on the market, they can add more compounds into the mix without needing to go through clinical trials each time. A key quote mentions the use of an “on-market” drug, so no fancy newly developed products for the time being:

“Follica’s proprietary in-office treatment regimen combines targeted scalp disruption using the Follica Hair Follicle Neogenesis (HFN) device, with a topical on-market drug to create and grow new hair follicles.”

Hair Follicle Neogenesis (HFN) and Skin Disruption

One unusual section of the above press release mentions a comparison with other skin disruption devices on the market. The Follica HFN device “significantly outperforms other skin disruption devices” when it comes to hair follicle neogenesis.

However, this seems to imply that using any kind of skin disruption  device can cause at least some brand new hair follicle growth. I should probably start at-home microneedling and dermarolling like tens of thousands of other people.

Follica’s approach entails generating an “embryonic window” in adult scalp cells via a series of short in-office treatments with its proprietary Hair Follicle Neogenesis (HFN) device. The scalp treatments last for just a few minutes, and they stimulate new hair follicle growth via stem cell stimulation. Following the wounding, a topical drug is applied to enhance efficacy by growing and thickening  the new hair follicles.

Follica Might Start off with Minoxidil

Update: November 25, 2019

A few days ago, “Toccata” emailed me a pdf document in which one small part mentioned that Follica was going to use Minoxidil as the compound after the microneedling. Reference: How does Minoxidil work to grow hair?

Apparently, this document was also posted on several hair loss forums. However, no-one initially saw the page 46 small Minoxidil part except “Toccata” as far as I could tell. The new HLT thread on last week’s Follica news is already 10 pages deep. At this point, it seems like a few people have realized what was missed before and the pdf has been repasted several times.

I did not want to share this document right away. On Twitter, I first asked several members of the Follica team to contact me as I wanted permission to share the cartridge, dropper and new patient hair growth photos. In the past, several Follica staff members have responded to my requests and questions.

However, I got no response from anyone this time around despite two attempts on November 21 and 22. I did not mention anything about Minoxidil to them, so there must be another reason for the secrecy.

I have now found the same document available online here (edit: no longer working). On page 46, it states: “Proprietary Minoxidil cartridges for use with smart dropper”. Crazy to see this after years of speculation.

For many years, most of us have assumed that Follica would use a compound that would at the very least be Minoxidil PLUS something else. Many people assumed that the second compound would be based on valproic acid, since Follica even has a patent in that area. So this news is a disappointment.

However, two important points to note:

  1. The above linked conference call pdf was published around three years ago and is old news. Moreover, things may change further before the end of 2020.
  2. It will be much easier to get initial US FDA approval for a microneedling based treatment that only involves the addition of Minoxidil. After all, topical Minoxidil has been approved as a hair loss treatment for decades. Some people even take the more dangerous oral Minoxidil to treat their hair loss.

Correct microneedling and wounding in combination with Minoxidil seems to give excellent results (e.g., see Rachita Dhurat and her India microneedling work). Most people who are experimenting with at-home microneedling are not doing it correctly. Hopefully, Follica’s micro-needling device in the hands of a professional will be much superior.

Even more hopefully, Follica will add other compounds into the mix down the road. Perhaps even something like wounding plus mesotherapy with Dutasteride.

November 21, 2019

New Follica update via Puretech’s latest November 2019 presentation. (h/t “Toccata”).

Follica FDA Filing in 2020

They seem to be calling the product FOL-004. Previously they have used FOL-001, FOL-002 and FOL-003 in various clinical studies. The final name is supposed to be the acronym Follica “RAIN”Note: The unrelated company Follicum labels its hair loss product as FOL-005!

Puretech has now raised its stake in Follica to 78 percent, indicating major optimism.

On page 32 of the presentation, it says that:

  • “Interim clinical readout of optimization study in AGA” was completed in 2019. Checkmark next to it on the left stands for completion.
  • In 2020, the company plans to get “Topline results from pivotal study in AGA” and also go through with FDA filing. Assuming data are supportive.
Follica Hair Growth Results
Follica FOL-004 hair growth in crown. Before and after photo.

On page 40, they have a crown hair growth before and after photo. Pretty decent results in my opinion. It says the after photo is 85 days post the “screening” before photo. Not sure how many treatments were required over those 85 days.

The still use the phrase “newly created hair follicles”. Created via the wounding and microneedling procedure using Follica’s proprietary new device.

Apparently, the procedure will just take 5 minutes. Fingers crossed, maybe we will finally get this much touted product to market by the end of 2020.

The below post was published on May 12, 2019. See bottom of page for possible Follica Trial recruitment information.

Puretech Health Pipeline

Follica Clinical Trial Schedule
Follica Pipeline via PureTech Health.

A few weeks ago, PureTech released its 2018 annual report. On page 31, you can find the summary for Follica. PureTech owned 62.3 percent of Follica at the end of 2018. Follica also updated its site recently as noted by one of this blog’s astute readers last month.

In the above linked PureTech report, the Follica page mentions that the company will start its “pivotal study” in 2019. They have already conducted three clinical trials in the past.

Per one definition, Pivotal study can mean Phase 3 or Phase 2. Per other definitions that I have read, it means Phase 2b. Either way, we are making major progress. Considering that Follica’s methodology involves wounding and then use of existing drug compounds on the scalp, perhaps they can get away with a faster approval process.

I have covered Follica numerous times on this blog, only to be disappointed at its speed of progress each time. However, I have some interesting news to share about the company that I will split between two posts.

Recruiting Volunteers

While going through their new website in more detail, I noticed that one of their clinical advisers was a Dr. Jeffrey Dover. His was the only name that I did not recognize in the list. A little bit of research, and I found that Mr. Dover works at SkinCare Physicians.

I then went to SkinCare Physicians’ Twitter feed, and lo and behold, the below Tweet from February 14 says it all. I have no idea if this recruitment period is over, but please only call them if you are certain that you fulfill all the requirements, including travel to Chestnut Hill, MA). And do not call them just to ask general questions!

Update: Had to remove the embedded Tweet after a request from one of the company’s representatives. She emailed me and said that they were bombarded with a huge number of calls, with many volunteers not fully realizing the very specific travel requirements. A number of callers even pleaded to get in despite living in different countries! And of course many called just to ask general hair loss questions despite my explicit warning above :-(