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.

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 the SKIN:SW stock ticker trend upwards in Monday’s trading?

Did I Underestimate RiverTown Therapeutics?

I first covered RiverTown Therapeutics and its RT1640 hair loss product briefly in June 2016. My opinion of this company at the time can only be described as being highly skeptical.

RiverTown Therapeutics RT1640

This changed slightly in December 2016, when I wrote a post on Cyclosporine and hair growth. In that post, I discussed RiverTown’s RT1640 in much more detail. This product consists of three small molecule drugs that each work via different pathways and mechanisms:

  1. Cyclosporine A — FDA approved and off-patent.
  2. Minoxidil — FDA approved and off-patent.
  3. RT175 — A proprietary new chemical entity. Still needs FDA approval.

The final topical product will therefore entail synergistically attacking hair loss via three distinct mechanisms. According to RiverTown:

“One drug promotes the growth and migration of new stem cells, one drug promotes the commitment of the follicular stem cells to become new hair and one protects the dermal papilla from the effects of DHT.”

Note that RT1640 is equally effective in men and women. RiverTown’s science page has some other items of interest.

Dr. David Weinstein

Last month, The New Yorker magazine ran a cover story about the pending arrival of a cure for hair loss. To my huge surprise, they gave the most amount of coverage to RiverTown Therapeutics and its co-founder Dr. David Weinstein. Of the large number of  companies working on a cure for hair loss, I would definitely not put RiverTown in my top 5. Nevertheless, I now do take this company much more seriously than I did in the past.

Moreover, RiverTown is one of the main companies that will be featured in a soon-to-publish article on future hair loss treatments from NewBeauty magazine. In that article, Dr. Weinstein claims that he is hopeful that RT1640 will be available in 2022 via prescription. Both as a topical lotion scalp hair loss product, and a cream eyebrow hair loss product.

I therefore finally contacted Dr. Weinstein about his RT1640 product. He was more than happy to respond to me, and sent the below photos of his own before and after RT1640 scalp hair. The second photo was in a pdf document and lost some quality after extraction. I may try to get a better version.

Dr. Weinstein told me that:

  • They are currently seeking funding to move into Phase 2 trials.
  • He is convinced that RT1640 grows back lost hairs in their original pigmented format. i.e., the drug can reverse achromotrichia.
  • The proprietary molecule RT175 has been tested in 650 patients to date, with no safety issues.

RiverTown Therapeutics RT1640

Rivertown Weinstein Hair