Category Archives: Follicum

Follicum Phase IIa Trials Delayed in Germany

Update March 19, 2020: Follicum’s Phase II Trial is delayed by the COVID-19 pandemic (h/t “Red”). Not surprising, although Mr. Gårdemyr’s response (see further below) suggested that all patients were already recruited. This latest article mentions patient recruitment as going well thus far, but not yet complete.

I suspect that most hair loss related clinical trials in the world will be delayed by at least 3-6 months due to the Coronavirus outbreak :-( And that is a best case scenario. The only good news this week seems to be a cessation of new COVID-19 cases in China.


Follicum FOL-005
Follicum.

February 1, 2020

I have written about Sweden-based Follicum and its FOL-005 hair growth product numerous times. Several days ago, Follicum announced that German authorities have granted the company approval to commence Phase IIa clinical trials for FOL-005. The go-ahead was granted by the German Medicines Agency (BfArM) and the German Ethics Committee.

Also see this recent article titled: “The rise of therapeutic peptides: Follicum at the forefront.” Key quote:

“Peptide-based drug candidates are more likely to reach the market compared to small molecule drug candidates.”

Follicum Phase IIa Trials in Berlin and Hamburg

The trial will comprise about 200 patients who will be treated with topical FOL-005 or placebo daily for 4 months. Results will be released in the fourth quarter of 2020. The upcoming phase IIa study will investigate the safety, efficacy and response to a topical formulation of FOL-005. Note that in 2018,  an injectable version of FOL-005 produced a good safety profile and hair growth results.

The press release states that patient recruitment will start soon. I contacted Follicum to see if any of this blog’s European readers would be able to volunteer as test candidates. However, the company’s chief business office Mr. Gunnar Gårdemyr replied in the negative. He said that all 200 test male patients for the trials have now been recruited and are from Germany.

The trials will be conducted at:

  1. Charité Clinical Research Center for Hair and Skin Science (“CRC”) in Berlin. A highly reputable institute that I have covered in the past on this blog.
  2. Hamburg-based proDERM, which just celebrated its 25-year anniversary. The have an interesting website section on hair care and hair removal.

About FOL-005

According to Follicum, FOL-005 is a proprietary peptide. Its development was based on research involving the human protein osteopontin. FOL-005 is a shorter sequence of osteopontin. The sequence has been slightly modified, but is still based on natural amino acids according to Follicum.

Follicum and Cassiopea Updates

Update: Yesterday, Follicum sent a new developments and update link to people on its email list. Sounds very encouraging. Proof-of-concept and top-line-data for their FOL-005 hair loss product are on target for 2020.

They have also entered into a collaboration with Bioglan to make their FOL-005 hair loss topical cream. Follicum is also on target to get final US patent approval soon that will grant rights through 2032.

February 9, 2019

I have covered both Follicum and Cassiopea numerous times on this blog in the past.

Follicum is based in Sweden and has done a stellar job in updating us regularly when it comes to the company’s peptide-based FOL-005 topical hair loss product. Projected release date: My guess is 2022, but one year sooner would not surprise me.

Cassiopea is based in Italy. Last year I mentioned how several very well known insiders of the hair loss industry have emailed me about their excitement in regards to Cassiopea’s Breezula topical antiandrogen product. Projected release date: Officially listed on their site as 2022.

Follicum Update

Follicum provided us with two updates this week.

  • The first was an important February 4th press release. In animal model in vivo testing, Follicum’s FOL-005 hair loss product was as successful as Minoxidil 5% in growing new hair. Moreover, while the latter must be used twice per day, FOL-005 need only be applied once per day.

Since results were dose dependent, I am hopeful that the company will test higher doses in future that may give even better new hair growth results. Considering that to-date, only two products (Finasteride and Minoxidil) have ever been officially approved to treat male pattern hair loss, this development is groundbreaking if true.

  • On February 9th, BioStock magazine published an interview with Follicum’s Research & Development director Maria Ekblad. Original Swedish version here. It seems like the latest version of FOL-005 that is being tested is a new formulation.

One interesting point made was that Follicum only managed to test the product for 3-month results in humans in recently completed Phase IIa trials. Ms. Ekblad hopes that longer-term usage will give even better results.

Follicum has historically worked with researchers at Charité Hospital (Berlin, Germany) and Bioskin (Hamburg, Germany). In late 2018, the company announced that they were now also working with the Centre for Skin Sciences at the University of Bradford (UK).

I would be very surprised if this once-a-day home use FOL-005 cream-like product ends up being less effective than Minoxidil. Unfortunately, it will probably not be released till 2021 at the  earliest.

Cassiopea Summarizes 2018

Yesterday, Cassiopea (Italy) provided an update of its 2018 results.

Both the company’s hair loss product (Breezula) and acne product (Winlevi) are based on a synthetic antiandrogen called Clascoterone. Six-month interim Phase II results for Breezula® used in solution form in men with androgenic alopecia demonstrated statistically significant improvement in:

  1. Target Area Hair Count (TAHC)
  2. Hair Growth Assessment (HGA)

Nothing too meaningful as yet, but: there is excitement in the hair loss world about this product due to some results that were presented by Cassiopea at a conference in 2018. I cannot divulge my sources.

I would be surprised if Breezula does not provide significantly superior results to Spironolactone (another antiandrogen) in regrowing hair. Otherwise, it would not be worth pursuing.

Moreover, this product will be in topical form, and most likely result in minimal side effects. Most oral antiandrogens have significant side effects.