Lainate, August 4, 2015
Cassiopea SpA (“Cassiopea”), a clinical stage specialty pharmaceutical company focused on developing and commercializing innovative and differentiated medical dermatology products addressed to the topical treatment of acne, androgenic alopecia (AGA) and genital warts announced today that the FDA has agreed to its clinical protocol in a special protocol assessment.
The protocol is titled, “A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) 1% Cream Applied Twice Daily for 12 Weeks in Subjects with Facial Acne Vulgaris”.
The agreed primary endpoints to be assessed for each treatment group at Week 12 are:
- Investigator’s Global Assessment (IGA) success defined as scoring 0 or 1 (clear or almost clear) AND at least 2-grade improvement from baseline.
- Absolute change from baseline in non-inflammatory lesion counts (NILC).
- Absolute change from baseline in inflammatory lesion counts (ILC).
Diana Harbort, CEO commented: “I am very pleased that the FDA agreed with our clinical protocol. Now we will execute our plan for the phase 3 trials. We expect to enroll the first patient in the last week of October.”
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. For further information on Cassiopea, please visit www.cassiopea.com.
Dr. Chris Tanner, CFO & Head of Investor Relations
Telephone: +39 02 868 91 124
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.