Cassiopea SpA said 57% of acne patients had at least a two-step improvement resulting in either clear or almost clear faces after 52 weeks of treatment with Winlevi during a late-stage study.
The phase 3 trial, named Study 27, enrolled 609 patients who had previously completed 12 weeks of treatment of either Winlevi or placebo in preceding trials. The patients were treated with Winlevi for an additional nine months. Of the participants enrolled in the study, 416 completed treatment for at least 26 weeks and 119 completed 52 weeks of treatment.
The Investigator General Assessment, or IGA, was used to measure the severity of the acne, with an IGA score of zero being clear skin and a score of one meaning almost clear skin. The study also recorded a two-step improvement on the trunk, resulting in a zero or one IGA score for 62% of the participants at 52 weeks of treatment. No drug-related adverse events were reported during the study.
Winlevi, or clascoterone, is a new topical anti-androgen treatment which works on hormones that can lead to skin lesions.
CEO Diana Harbort said these results complete the data set necessary to file a new drug application for Winlevi.