Earlier today, commentator “Bekoo” posted some groundbreaking news about Histogen in regards to their men’s hair loss product. The information he posted was part of an article that appeared a few days ago in the San Diego Tribune on July 12th 2018.
Note that Histogen is headquartered in San Diego, so the company is often covered in the city’s main local newspapers.
The title and gist of this new article is in regards to Histogen’s women’s hair loss product (HSC660) trials, which I already discussed earlier this month. So even though it was in my Google alerts, I was never planning to read the article in it’s entirety… until “Bekoo” saved us and posted his findings today.
FYI — they have a women’s before and after HSC660 hair growth photo in the newspaper story.
Histogen Starts Phase 3 Trials in Mexico
- By far the biggest news is that Histogen has started Phase 3 clinical trials in Mexico for its men’s hair product. This product is called “an earlier version of HSC660” in the San Diego Tribune article, so might be slightly different from the newer women’s HSC660.
Note that in 2016, Histogen estimated that their men’s hair loss product would be available in Mexico in 2018. They were planning to start Phase 3 trials in Mexico “soon” per that 2016 post of mine. So it looks like they got delayed by 1.5 years or so. Better late than never of course.
- Also, per CEO Dr. Gail Naughton, they anticipate success with these Phase 3 trials and are looking towards commercialization:
“We’re in very late-stage negotiations with some huge retail partners. A deal should be concluded in the next few months.”
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?