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Cassiopea Announces Breezula (CB0301) Trial Results

"The top line results of the planned six-month interim analysis for the phase II dose ranging study for Clascoterone (Breezula®) solution in androgenic alopecia in men demonstrated statistically significant improvement for Target Area Hair Count (TAHC) and directional improvement for Hair Growth Assessment (HGA)."

Cassiopea is also testing Clascoterone (the active ingredient in Breezula/CB0301) for acne, and is much further along with these trials (Stage 3). So, in theory, this new hair loss treatment could be available pretty soon.

"The results of the two pivotal phase III clinical trials for the topical anti-androgen Clascoterone (Winlevi® cream 1%) in acne demonstrated highly statistically significant improvements for all primary and secondary clinical end points and that the drug is generally safe and well tolerated."

You can find out more about CB0301/Breezula and how it works here:

As a topical solution, this treatment could be particularly beneficial for people who suffer from finasteride/Propecia side effects.

Cassiopea has announced 12 month results of CB0301/Clascoterone/Breezula for hair loss. The results sound positive:

"statistically highly significant changes vs. vehicle were observed in all active groups with the highest change observed in the 7.5% [twice daily] group [...] These results indicate that Clascoterone stops the loss of hair and grows new hair."

"Diana Harbort, CEO of Cassiopea, said: “We are very pleased by these excellent results which show that our topical anti-androgen is efficacious in the treatment of AGA with side effects similar to placebo and importantly without any systemic side effects. Based on these results, we plan to meet with the FDA mid-year to discuss the planned six-month Phase III trials in men. Hopefully, we will begin our Phase III program in 4Q 2019."

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Will this be better than minoxidil and propecia? When will it be available?


Quote from Guest on April 22, 2019, 2:31 pm

Will this be better than minoxidil and propecia? When will it be available?


Almost definitely more effective than minoxidil. The initial phase 2 trial had a group applying clascoterone/CB0301 and a group applying minoxidil, and the clascoterone/CB0301 outperformed minoxidil. Plus, this latest dose-ranging phase 2 trial is likely to have achieved even better results than the initial trial.

As for whether it's more effective than Propecia, possibly. It's certainly less likely to cause side effects. Also, the two treatments can be used together which could lead to even better results.

Also, the quote from Cassiopea says: "Clascoterone stops the loss of hair and grows new hair." - pretty big if true.