Cassiopeia has just released excellent news regarding very positive interim Phase 2 results of Breezula. They now also call the product by its new chemical name of Clascoterone. Note that these are interim 6-month results and the trial is still ongoing.
Update: Cassiopeia stock almost doubled in the past week. This was due to their July 10 press release regarding positive Phase 3 clinical trial results for their topical anti-androgen acne cream Winlevi 1%. This Winlevi (Clascoterone) product is very similar to Breezula (h/t Tommy).
Breezula (Clascoterone) Timeline
— I first covered Italian company Cassiopeia’s Breezula topical anti-androgen product in 2014. At the time, the product was known as CB-03-01. And Cassiopeia itself was known as Cosmo Pharmaceuticals. The CB-03-01 product was touted as a treatment for acne, hirsutism and male pattern baldness (MPB).
— In 2016, I provided an update on Breezula concerning favorable Phase 2 proof-of-concept results.
— In my post about the AHRS conference in May 2018, I mentioned how one of my insider sources told me that there was a great deal of excitement surrounding the Breezula presentation. This source was clearly on to something.
Clascoterone Phase 2 Results
Per this latest 6-month interim analysis of phase 2 dose ranging clinical trials for Clascoterone (Breezula®):
- When it comes to target area hair count (TAHC): 7.5% Clascoterone solution twice per day gave similar results after 6 months as oral Propecia did after 12 months. It is expected that 12-month results from Clascoterone will be even superior.
- The ongoing double-blind trials at 6 sites in Germany involve a sizable 404 male patients. They are being tested at one of four different dosages, or placebo.
- Cassiopea expects that the side effects from topical Clascoterone will be far less in comparison to those from existing oral anti-androgen type drugs. Clascoterone does not interfere with the hormonal profile of patients, especially testosterone. To date, no sexual side effects have been seen in clinical trials.
- The company will soon start proof-of-concept (POC) trials for women.
- Final Phase 3 trials for men are also being planned for the future.
- If approved, Clascoterone would be the first FDA-approved topical anti-androgen product for the treatment of androgenetic alopecia.
- Cassiopeia’s product pipeline page has a Breezula market launch goal of 2022. The related acne product will come out by the end of 2020.
- Will SKIN:SW trend upwards in Monday’s trading?