Cosmo's anti-androgen cream passes Ph I test

Lainate, Italy-based Cosmo Pharmaceuticals SpA has reported positive results from the first Phase I trial of its novel anti-androgen 1% cream, CB-03-01. The results showed that the drug was well tolerated both locally and systemically and devoid of measurable side effects at all the dosage levels tested.

CB-03-01 is a New Chemical Entity, belonging to the family of cortexolone derivatives, patented by Cosmo as an anti-androgenic drug and indicated for the topical treatment of androgen-dependent skin disorders including acne, hirsutism or androgenetic alopecia.

The trial was designed as a randomized, double-blind, placebo-controlled, single ascending doses study to assess drug safety, tolerability and pharmacokinetics following single-dose administration.