Date: 2014-07-08
Type of information: Results
phase: 2
Announcement: results
Company: Cosmo Pharmaceuticals (Italy)
Product: CB-03-01 (cortexolone 17alpha-propionate)
Action
mechanism: CB-03-01 is a molecule that acts at the level of the skin androgen receptor, blocking testosterone and dihydrotestosterone from binding to the receptor in the cell. The molecule has a unique mechanism that acts at the skin surface, and is quickly metabolized to free inactive cortexolone, a substance naturally found in the body. The molecule has been evaluated in a variety of animal models as well as initial human trials in Europe for acne and androgenic alopecia. The results of these studies demonstrate that CB-03-01 appears to have potent anti-androgenic activity without significant local or systemic side effects.
Disease: acne
Therapeutic area: Dermatological diseases
Country: USA
Trial
details: The Phase II acne study is designed as a multi-center, double-blind, placebo controlled, dose-escalating study to evaluate the safety and efficacy of CB-03-01 in the treatment of patients with mild to moderate facial acne vulgaris. The clinical trial is intended to enroll approximately 360 patients, with a 12 week treatment period. Primary endpoints include the proportion of patients achieving success, based on the Investigator Global Assessment (IGA) scale, and the absolute change from baseline for inflammatory and non-inflammatory lesion counts at 12 weeks. Secondary endpoints include the proportion of patients achieving success based on the IGA at 8 weeks, and lesion counts at 8 weeks.
Latest
news: * On July 8, 2014, Cosmo Pharmaceuticals announced that it had successfully concluded the phase II acne trials of CB-03-01 and that, prior to the upcoming end of phase II meeting with the FDA, both Cosmo and Valeant Pharmaceuticals International, the licensee, had agreed that it was preferable for both parties for Cosmo to continue developing the drug. Consequently both Cosmo and Valeant agreed to unwind the present agreement and replace it with an agreement granting Valeant a right of first refusal should Cosmo decide to license out the drug after completing its development. * On March 12, 2012, Cosmo Pharmaceuticals has announced that the Investigational New Drug Application (IND) for CB-03-01 for acne has been accepted by the FDA. Cosmo also announced that in order to conduct the phase II clinical trials in the US, it has entered into an agreement with Intrepid Therapeutics, who will now proceed with a double-blind, randomized, placebo-controlled Phase II clinical trial in acne. Previously, a European Phase II pilot study with CB-03-01 demonstrated positive results in a three arm, randomized, double-blind, parallel-group, controlled study versus placebo and versus Retin-A® 0.05% cream, in facial acne vulgaris. The trial showed that CB-03-01 was clinically superior to placebo and to Retin-A® 0.05% cream in the treatment of facial acne vulgaris after 8 weeks of drug application.
