CB-03-01 acts by blocking testosterone (T) and dihydrotestosterone (DHT) from binding to the receptor in the cell.
The multi-center double-blind placebo controlled dose-escalating Phase II acne study will enroll around 360 patients to assess the safety and efficacy of CB-03-01 in the treatment of patients with mild to moderate facial acne vulgaris.
In the trial, primary endpoints include the proportion of patients achieving success and the absolute change from baseline for inflammatory and non-inflammatory lesion counts at 12 weeks.
Secondary endpoints of the study include the proportion of patients achieving success based on the IGA at eight weeks, and lesion counts at eight weeks.
Intrepid president and CEO Diane S. Goostree said the agreement with Cosmo and the acceptance of the Investigational New Drug Application (IND) allow them to move forward with the development of a new molecule for the dermatology market.
"We are also conducting further non-clinical studies to prepare for an additional IND filing and clinical studies to evaluate CB-03-01 in the treatment of androgenic alopecia (hair loss),"Goostree added.
Previous European Phase II pilot study with CB-03-01 reported that CB-03-01 was clinically superior to placebo and to Retin-A 0.05% cream in the treatment of facial acne vulgaris.