Category Archives: Breezula

Cassiopea’s Breezula Phase II Results Very Positive

Update November 13th: Cassiopea’s women’s hair loss clascoterone solution Phase II trials starting soon in Germany.


I have covered Italian company Cassiopea since 2014 (when it was called Cosmo Pharmaceuticals). The company is developing a topical anti-androgen hair loss product named Breezula (originally called CB-03-01). The chemical name for this product is Clascoterone.

Breezula will be available for both men and women. Several of my well known physician contacts in the hair loss world have told me great things about this product. Their feedback is based on what they saw at conferences or heard from colleagues.

Breezula Phase II Trials Very Successful

In July of last year, Cassiopea stated that the interim Phase II clinical trial results for Breezula were very positive. Today, they released twelve month Phase II trial results with the same conclusion:

Cassiopea Announces Very Positive Phase II Twelve Months Results for Breezula® (Clascoterone) in Treating Androgenetic Alopecia.

The presentation of the results is confusing, detailed, full of acronyms and somewhat open to interpretation. Note that “BID” in there stands for “twice per day” after conversion from Latin. Hopefully they release before and after photos at some point.

Also note that the previous 6-month interim report had 375 subjects, and the 12-month report has 344 subjects. The trial was conducted in Germany.

Breezula Target Area Hair Count Increase

Best case result highlighted in yellow (14.3 new hairs per square centimeter after 12 months of 7.5% BID dosage):
Breezula Hair Count Increase

 

Breezula Target Area Hair Width Increase

Best case result highlighted in yellow (762.5 um width increase after 12 months of 7.5% BID dosage):
Breezula Hair Width Increase

 

My gut feeling is that Breezula will be at least as effective as Finasteride and Minoxidil.

Clascoterone Summary

Some key points from the above linked article from Cassiopea:

  • If approved, Breezula (Clascoterone) will be the first FDA-approved topical anti-androgen for the treatment of androgenetic alopecia.
  • Moreover, it would also be the first new drug approved for treating androgenetic alopecia since 1997. That year was when Propecia (aka Finasteride) was first approved to treat hair loss. That year was also when Tiger Woods last won the Master’s before this past weekend’s surprise.
  • Based on these great results, Cassiopea plans to proceed with 6-month Phase III trials in men in the fourth quarter of 2019, after consultation with the FDA. The company is also going to start proof-of-concept trials in women.
  • Breezula works by blocking dihydrotestosterone (DHT) interaction with hair follicle androgen receptors.
  • Clascoterone does not interfere with testosterone and other hormones in male subjects. Libido and sexual behavior changes have so far not been observed in clinical trials. Moreover, due to its rapid metabolism and localized activity, Clascoterone (Breezula) does not produce any systemic side effects.

In the past, I used to often state that perhaps an initial cure for hair loss would entail the usage of a cocktail of products. Each working via different mechanisms and chemical or biological reactions.

It is looking likely that Breezula will be one of the main products in this cocktail.

Note that Clascoterone cream to treat acne will be released by Cassiopea before Breezula. The acne product is called Winlevi.

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?