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ARTICLE | Clinical News

Cassiopea planning NDA for acne candidate after Phase III meets endpoints

August 10, 2018 12:20 AM UTC

Cassiopea S.p.A. (SIX:SKIN) said twice-daily topical Winlevi 1% clascoterone (CB-03-01) for 12 weeks met the three co-primary endpoints vs. placebo in both the Phase III Study 25 and Study 26 to treat acne. The company plans to submit an NDA in 1Q19 for the product in the indication.

On the first co-primary endpoint, 16.1% and 18.7% of patients who received Winlevi achieved an Investigator's Global Assessment (IGA) score of clear or almost clear with a ≥2-grade improvement at week 12 vs. 7% and 4.7% of patients who received placebo, respectively (p=0.0012 and p<0.0001, respectively). On the other co-primary endpoints, Winlevi significantly reduced absolute inflammatory and non-inflammatory lesion count from baseline to week 12 vs. placebo...

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Cassiopea S.p.A.