Date: 2012-03-12
Type of information: R&D agreement
Compound: CB-03-01 (cortexolone 17alpha-propionate)
Company: Cosmo Pharmaceuticals (Italy) Intrepid Therapeutics (USA)
Therapeutic area: Dermatological diseases
Type agreement: R&D
clinical research
Action mechanism: CB-03-01 is a molecule that acts at the level of the skin androgen receptor, blocking testosterone (T) and dihydrotestosterone (DHT) 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, alopecia
Details: Intrepid Therapeutics, Inc., a specialty pharmaceutical company based in San Diego focused on the development of innovative prescription products for dermatological indications, has entered into an agreement with Cosmo Pharmaceuticals to conduct the Phase II clinical trials in the US for Cosmo’s novel topical anti-androgen molecule, CB-03-01 (cortexolone 17?-propionate). Intrepid Therapeutics also announced that the Investigational New Drug Application (IND) for CB-03-01 for acne has been accepted by the FDA and the company will now proceed with a double-blind, randomized, placebo-controlled Phase II clinical trial in acne. Intrepid Therapeutics is 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).
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