Category Archives: Cassiopea

Cassiopea’s Breezula is the Real Deal

Cassiopeia Logo

Cassiopea 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: Cassiopea 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 Cassiopea’s Breezula topical anti-androgen product in 2014. At the time, the product was known as CB-03-01. And Cassiopea 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.
  • Cassiopea’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?

Update on Breezula (aka CB-03-01)

In 2014, I wrote about a new yet to be released topical antiandrogen product called CB-03-01. Historically, antiandrogen products have usually been ingested orally and often led to adverse side effects. Early reports suggest that topical CB-03-01 has no significant side effects.

In 2015, the Italian company (Cosmo Pharmaceuticals) that was compounding CB-03-01 changed the product’s name to the unusual Breezula. Moreover, Cosmo itself was renamed as Cassiopea. I wrote about those developments here.

Breezula Phase 2 Results

Yesterday, Cassiopea released an interesting PowerPoint presentation summarizing 2015 and projecting the outlook for 2016. Edit: Link no longer working.

For us hair loss sufferers, pages 18-22 summarizing Breezula’s Phase 2 Proof of Concept (PoC) results is the most important section.

To summarize in brief:

  • 95 patients were enrolled in a double blind study that lasted for 6 months and ended in December 2015.
  • 31 patients were on Breezula 5%, 31 patients were on Minoxidil 5% and 33 patients were given nothing except a vehicle (i.e., placebo).
  • Of the 95 patients, 78 lasted till the end of the 6-month treatment period, and 73 of those were deemed to have completed the protocol without any violations. Of those 73 patients, 23 were on Breezula, 25 were on Minoxidil and 25 were on a placebo. A fairly even distribution.
  • 39 percent of patients on Breezula had at least some improvement in hair growth, compared to 36 percent of those on Minoxidil. 26 percent of patients on Breezula had at least some worsening in hair growth, compared to 16 percent of those on Minoxidil. Status quo was maintained in 35 percent of Breezula patients versus 48 percent of Minoxidil patients.
  • Later in 2016, Cassiopea will commence further dosing related trials for Breezula. I wonder if they will compare the effectiveness of higher doses to the effectiveness of the much more rarely used Minoxidil 15%?

I was pleased to see the results. Overall, Breezula seems as good as Minoxidil, and since the latter is not an anti-androgen, we can use both products topically on our scalp for two separate positive effects. Perhaps we can also add topical Bimatoprost and topical Finasteride to that combo later this year, and then we would have a quartet of topical products, each tackling a different mechanism of balding.

Future Release Date

Of course Breezula is still years from release (even if we assume they can speed up phase 3 trials like is the case in Japan, with newer regulations), but some people on hair loss forums are purchasing it illegally or even making it at home. An even more optimistic scenario is the addition of Samumed’s topical SM04554 to the mix whenever that comes out. It would be funny if in 2020, I started applying a quintet of topical products to my scalp and then suddenly a simple cure for hair loss came out that made all those topical products obsolete.

For younger people who have only been balding for a few years or less, such incremental developments are probably not too exciting. For those of us who have been following the hair loss industry for many more years, it is very pleasing to finally see new products arriving. It is ridiculous that there have only ever been two products officially FDA approved to tackle hair loss — 1) Finasteride and 2) Minoxidil.

***Note that on page 8 of the PowerPoint presentation they have labeled CB-03-01 as “Winlevi” and CB-03-11 as “Breezula”. Winlevi (for acne) and Breezula (for hair loss) contain the same key antiandrogen ingredient (a steroid belonging to the family of cortexolone derivatives), but in different formulations.