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:
- 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.
- 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.
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
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.
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 🙁
The post Follica Pivotal Trial in 2019, Phase 3 in 2020 appeared first on Hair Loss Cure 2020.