Lainate – December 11, 2017 – Cassiopea SpA (SIX: SKIN) today announced that the last subject in the phase II dose ranging trial of Breezula for androgenic alopecia has been enrolled.
The multicenter 12-month study enrolled male subjects between 18 and 55 years of age with mild to moderate androgenic alopecia and was designed to enroll 400 subjects in a five-arm study enrolling 80 subjects per arm. The study was conducted in Germany.
The 5 arms used different strength dosages ranging from 2.5%, 5.0%, 7.5% and vehicle BID (twice a day) and 7.5% QD (once a day).
The first patient was enrolled in June 2017, 431 subjects were screened and 404 patients enrolled.
The Co-Primary Endpoints are:
- Changes from baseline in TAHC (“total assessed hair count”) in number of non-vellus hairs at month 12
- The subject’s evaluation of treatment benefit via the HGA (“hair growth assessment”) question at month 12
Diana Harbort, CEO of Cassiopea SpA, comments: ”Physicians and patients have very few treatments for androgenic alopecia despite the fact that so many patients are concerned and affected by it. One of the only effective products on the market, oral finasteride, which has substantial side effects and cannot be used by women, is known to attain approximately 75% of its 12-month effectiveness after 6 months of treatment. We will thus perform an interim analysis after 6 months to make an assessment of the best dosing regimen and expect to be able to provide top line results in late H1 2018.”
Cassiopea is a clinical-stage specialty pharmaceutical company focused on developing and commercializing innovative and differentiated medical dermatology products. Initial focus is on the topical treatment of acne, androgenic alopecia (or AGA) and genital warts. The portfolio comprises four unencumbered clinical candidates, for which Cassiopea owns the worldwide rights. The company plans to commercialize the products directly in the US and partner the products outside of the US. For further information on Cassiopea, please visit www.cassiopea.com.
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Dr. Chris Tanner, CFO & Head of Investor Relations
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Some of the information contained in this press release may contain forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cassiopea has no obligation to publicly update or revise any forward-looking statements.