Category Archives: Follicum

Follicum Phase I/IIa Results

I first covered Swedish company Follicum and its FOL-005 hair growth product exactly two years ago. I wrote another post on the company early last year. Thereafter, I have only covered them in passing as part of my once a month “brief items of interest” posts.

Most recent developments were minor and related to country specific patents and so forth. My main reasons for following this company are due to the facts that they are conducting their research at the prestigious Charité Hospital in Berlin, Germany; they have an impressive group of hair loss related scientific advisers; and they have been providing us regular news updates.

Follicum 2016 Annual Report

Earlier today, a person by the name of “Rickard” e-mailed me and asked me to check out Follicum’s latest report. When I then went to Follicum’s website, the news section had not been updated since last year, while the press release section had several updates from last week, one of which was the release of their annual 2016 report. It is in Swedish, but can be downloaded and then translated via “Google Translate”. I learnt some interesting new things in the report:

  • Follicum was founded in 2011 based on research from Lund University by Anna Hultgårdh Nilsson and Pontus Dunér.
  • The company’s technology entails isolating the protein osteopontin, which regulate hair growth.
  • “FOL-005 is a section of the protein, gathered in a small molecule (peptide) where two amino acids are deleted and replaced by a third”.

Follicum Timeline

  • Company inception (2011).
  • Preliminary study on live mice (2012).
  • Study on human skin in vitro (2013).
  • Study on human skin transplanted to mice (2015).
  • Toxicity study for three months (2016).
  • Clinical Phase I study of subjects (implemented 2016-2017).
  • Clinical Phase IIa study – a limited effect on the study subjects in the phase I study (2017).

At first, I was not sure about writing a new post on Follicum just because of the above annual report. However, thanks to commentator “Hopeful” posting this new link, I realized that this was probably what “Rickard” was talking about earlier.

Clinical Study Shows 8 Percent Hair Growth

After translating this new link, it seems like Follicum’s FOL-005 resulted in an 8 percent increase in hair growth in patients treated at the Charité Hospital in Berlin in phase I/IIa clinical trials. CEO Jan Allenfal states that this compares favorably to existing treatments that results in a 4-14 percent average increase in hair count. With further testing and experimentation of dosage and composition, FOL-005 is likely to results in even superior results.

I think its great to get a third option to the two main current treatment options (Finasteride and Minoxidil). Even something new that only maintains existing hair would be very welcome (especially for those such as myself who are not keen to reduce their DHT levels for many years continuously via taking Finasteride).

However, will FOL-005 grow back hair in those who are already severely bald? Not likely.

Hair Loss World News Updates

Lots of new developments in the world of hair and biology during the past month.

Hair loss news first:

— The most important news is courtesy of HLT, which several days ago interviewed people from the Dr. Tsuji/RIKEN/Organ Technologies team (but not Dr. Tsuji himself). Interview publication has been delayed due to Japan’s “Respect for the Aged Day“, but according to the HLT admin, he has been given permission to divulge the following regarding the Tsuji team’s work:

“Human trials to begin 2018. Commercial availability still on track for 2020.”

While not surprising to hear after the Kyocera partnership news in July of this year, it will hopefully put many people’s minds at ease.

— Thanks to who else but JAK superfan “nasa_rs” for letting us know that Aclaris Therapeutics updated its pipeline page and finally added its topical JAK inhibitor product (ATI-500003) for men with androgenetic alopecia (AGA). Interestingly, all four of its JAK products are now shown to be 80 percent or so through the pre-clinical phase and are on the verge of entering Phase 1 trials.

According to the pdf from the company’s September 14th webcast, proof-of-concept (POC = Phase 1 and Phase IIA) trials for the company’s alopecia areata (AA) drugs will commence in the first and second quarter of 2017. Considering that JAK inhibitors Ruxolitinib and Tofacitinib have already been FDA approved and in use for around 5-6 years, the big question is whether this will allow faster progression of Phase 1 clinical trials for Aclaris’ various JAK products? According to wikipedia, there are currently seven other JAK inhibitors in clinical trials.

— Long-time perpetual disappointment Follica, which had earlier announced initiation of a registration study in the second half of 2016 has delayed plans till the first half of 2017. A recently announced best-case product release scenario of 2018 by Follica now sounds just as unlikely as hyper-prolific commentator “mjones” ever meeting with his hero and Follica founder Dr. George Cotsarelis.

— In my June “brief items of interest” blog post, I mentioned that Allergan had commenced phase 2A clinical trials for Setipiprant to treat androgenetic alopecia. The company updated its clinical trial page again in August and many of their centers in the US are currently recruiting volunteers. It seems like Skincareresearch will even pay you up to $650 for participating.

Allergan also updated its Bimatoprost clinical trial page in August. Study is expected to be completed very soon in October 2016.

Follicum updated its website regarding the second part of their clinical phase I/IIa study for their FOL-005 hair loss product. I like the fact that they are undertaking some of this work at the reputable Charité-Universitätsmedizin Berlin in Germany. Follicum also sent out an e-mail to many people (one of whom was myself) and here is the gist of it:

“The study is divided in two parts, a single ascending dose part and a multiple dose part. Multiple dosing has begun on healthy volunteers. The study has now finalized recruiting volunteers and is fully recruited, it is being carried out in Germany at: Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin Berlin, Germany. As this is a regulated clinical trial results have to be published once the trial is completed and all the results have been analysed, which is estimated to be in January 2017.”

A conference on the Wnt signaling pathway ran from 14th-17th September in the Czech Republic. Interestingly, Samumed was one of the main sponsors. Of even more importance, it seems like Samumed made an extremely interesting and well received presentation at the 13th Medical Innovation Summit in London on September 17th 2016. Why do I say that without seeing the actual presentation? Because of numerous Tweets praising it on Twitter.

— One of the commentators on this forum named “skin” made some interesting comments in this dermarolling and Minoxidil post of mine that are worth reading. Especially if you are considering trying out dermarolling.

Lengthy article on hair loss, including some thoughts from Dr. Claire Higgins.

Scalp micropigmentation video on Quartz.

Troy Hurtubise wants to defeat hair loss. This is about as far fetched as it will ever get in our already diverse hair loss cure world.

Donald Trump lets Jimmy Fallon mess up his hair.

And now on to medical items of interest:

— Burned firefighter Pat Hardison continues to thrive one year after his face transplant. Pretty amazing progression.

— I have covered Zion Harvey 3 times on this blog now. His 1-year post double hand transplant update video is inspiring. Note that he has also had a kidney transplant and has prosthetic legs too:

— MIT scientist claims that his Elysium Basis pill is the one when it comes to the fountain of youth. More relevant to us (and discouraging) is the below quote:

“Guarente has been taking Basis for two years, but it’s a good bet that he is not among those who have observed hair growth as one of the pill’s effects.” 

— World’s formerly fattest man who lost 658 pound after gastric bypass surgery in 2010 will now get a second free surgery to remove excess skin.

— Embryos from skin cells instead of from eggs? Would mean real freedom for both men and women.

Infertile mice give birth due to 3D printed ovaries.

Stem cell therapy restores arm and hand movement for a paralyzed man.

New drug to treat Alzheimer’s could be very effective.

Lysyl oxidase inhibition could eliminate scar formation.

Cold plasma to heal non-healing wounds.

— CRISPR’d vegetables are now here.

— With Japanese electronics behemoth Kyocera partnering with Tsuji/RIKEN and their cell based work, it is perhaps not surprising that in the US General Electric now aims to build a $1 billion business “offering vital manufacturing tools for a coming wave of cell therapies.