Category Archives: Follica

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 :-(

Dr. Dhaval Bhanusali will Answer your Questions

This morning, Follica announced positive interim data in its Phase II clinical trials. They are now on track to start pivotal trials at the end of 2019, which I discussed a month ago. In this latest press release, they have some interesting quotes from Dr. Ken Washenik and Dr. Rox Anderson.

Dr. Dhaval Bhanusali
Dr. Dhaval Bhanusali: Follica Clinical Adviser.

One of Follica’s well known clinical advisers, Dr. Dhaval Bhanusali, has kindly agreed to answer reader questions! We have been going back and forth about this for a few weeks, but it seems he is now ready after this latest news has become official.

I think that this is the first time that I have had success with anyone important on Follica’s team responding in person. Dr. Bhanusali works with various celebrities (e.g., Martha Stewart) and even starred in a Men’s Health article.

Readers on this blog have at various times posted links to Dr. Bhanusali’s Instagram and Twitter accounts.

Dr. Bhanusali told me the following:

“There are lots of things I can’t say because of NDAs and also legally because companies like Follica have investment partners that are publicly traded (so legally, not allowed to, even if I want to). But happy to talk in generalities at some point and genuine thoughts on things!

I haven’t kept up as much as I should have on hairloss websites, but I think the internet is unfortunately full of companies that take advantage of patients/consumers with false claims and it is super sad. Happy to help if you think I can educate on things that help patients long term.”

So please keep the above in mind when asking your questions in the comments to this post.

Follicum, Follica and French Fries in February

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.