Category Archives: Follicum

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.

FOL-005, Follicum

Follicum Latest Summary

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I have covered Swedish company Follicum a number of times in the past on this blog, with my first post about them going back almost three years. You can click on the company name that is right above the title of this post to read all my past posts about Follicum.

The company is working on an interesting modified human protein based product called FOL-005, which can both reduce hair growth (great for those with excessive body hair) and increase hair growth (great for those with less scalp hair).

After I published the recent news about Follicum’s phase 2 trials in my last post, a representative from the company reached out to me several days ago and provided the excellent below summary of where the company currently stands.

Follicum FOL-005 for Stimulation of Hair Growth

Follicum has, in collaboration with international R & D partners (e.g. Charité Hospital, Berlin, Germany) evaluated FOL-005 (a peptide) in different models for regulation of hair growth. Both in-vitro and on humans. Our development process may briefly be described as follows:

  • Trials on mice (2012).
  • Trials on human tissue in-vitro (2013).
  • Trials on human tissue transplanted on mice (2015).
  • Toxicity trials, three months (2016).
  • Clinical phase I/IIa trial on humans (2016/2017).
  • Development of a topical formulation for FOL-005 (2017/2018).
  • Beginning of 2018 Follicum will start a clinical trial (phase IIa) in Alopecia on scalp. This time including 60 alopecia patients. The study will read out during end 2018.

Preparing for further clinical trials of FOL-005, Follicum conducted two separate three month toxicity trials during 2016. Both trials showed FOL-005 to be safe for further administration.

During the period from late 2016 to early 2017 the first clinical trial was carried out on healthy humans at the Charité Hospital of Berlin. The main objective of the trial was to confirm the safety of the drug, FOL-005, and to measure effect and response. The results showed, first of all, that the treatment was safe while also showing a considerable increase in hair growth.

In all, 76% of the trial participants with the second lowest dose of FOL-005 during the trial showed increased growth. At this specific dose, the growth was stimulated roughly 8% compared to before treatment. The increase is statistically verified (p=0,0038). Please note that this was a short 3 month trial on thigh and that the next study will be on 60 Alopecia patients on scalp.

We are in parallel with the clinical program developing three different topical formulations from which we will select the one that is most attractive during Spring 2018 to be used in phase IIb clinical trials 2019. The prototype formulations are the following:

  1. Powder formulation – FOL-005 in emulsion of lipid-based suspension.
  2. Cream – nanoparticles of FOL-005 in lipid-based suspension.
  3. Gel – FOL-005 incorporated in polymer nanoparticles.

Note that the company’s CEO Dr. Jan Alenfall has a number of mostly Swedish videos on youtube (although with English presentation slides in some). One useful recent one is here.