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Cassiopea Hails Breezula's 'Good Hair Day' And Plans FDA Talks On Phase III

 
• By Sten Stovall

Italy-based Cassiopea says “very positive results” from Breezula's 12-month Phase II alopecia trial support progressing  it to Phase III, particularly given the clean safety profile.

BaldingMan
Cassiopea Will Now Talk With FDA About Phase III trialing in men • Source: Shutterstock

Cassiopea SPA is to initiate talks with the US Food and Drug Administration on Phase III trials in men with Breezula (clascoterone) and proceed with plans for proof of concept studies in women after the topical anti-androgen produced "very positive" 12-month Phase II data in males.

Final 12-month Phase II data showed Breezula met one of two co-primary endpoints, demonstrating statistically significant improvements in the change from baseline in non-vellus target area headcount versus placebo, and generated

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