FDA approves Phase III trial protocol for Winlevi (CB-03-01) for treatment of Acne- Cassiopea SpA

Cassiopea SpA announced that the FDA has agreed to its clinical protocol in a special protocol assessment for Winlevi (CB-03-01). The protocol is titled, “A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17?-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:

1. Investigator’s Global Assessment (IGA) success defined as scoring 0 or 1 (clear or almost clear) AND at least 2-grade improvement from baseline
2. Absolute change from baseline in non-inflammatory lesion counts (NILC)
3. Absolute change from baseline in inflammatory lesion counts (ILC)