Category Archives: Cassiopea

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.

Cassiopea’s Breakthrough Acne Treatment

Update: November 8 2019 — Cassiopea announces US FDA reviewing new drug application (NDA) for clascoterone cream 1% to treat acne.


I have covered Italian company Cassiopea numerous times on this blog. Primarily due to its Breezula topical product for male pattern hair loss. Earlier this year, Cassiopea announced very good 12-month Phase 2 clinical trial results for Breezula.

Clascoterone, Winlevi and Acne

Cassiopea is also working on an acne product called Winlevi. Both Breezula and Winlevi are based on the same key ingredient: Clascoterone. However, the dosage in Winlevi is significantly lower at 1%. Winlevi is almost ready to come to market per Cassiopea’s product pipeline.

Cassiopea Acne Hair Loss Pipeline

 

Earlier this week, Cassiopea made a major announcement. The company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for clascoterone cream 1% for the treatment of acne.

Some interesting points in the press release and my thoughts:

  • Clascoterone cream 1% targets androgen receptors at the site of application. This inhibits the local (skin) effects of dihydrotestosterone (DHT). Apparently, DHT is a key driver of acne lesion development. Most people wrongly assume it is solely testosterone.
  •  This acne treatment product will be safe to use in both males and females.
  • If approved, clascoterone cream 1% will represent the first new mechanism of action in the treatment of acne in almost 40 years. Interestingly, if Breezula is approved for hair loss in 2021, it will be the first new topical or oral treatment for hair loss in almost 25 years.