COSMO PHARMACEUTICALS N.V. Cosmo Pharmaceuticals N.V. announced the beginning of the phase III trials of clascoterone solution in males for the treatment of androgenetic alopecia. The phase III trials will evaluate and assess the use of clascoterone topical solution in males. AGA is the most common form of hair loss and a substantial market with high unmet needs.
It is an extremely common disorder that affects roughly 50% of men. Clascoterone topical solution is a potential first new mechanism of action in AGA in nearly three decades. The program consists of two identical 6-month phase III, multicenter, prospective, randomized, double-blind, vehicle-controlled studies, to evaluate the efficacy and safety of topically applied Clascoterone (Cortexolone 17-Propionate) Solution for the treatment of androgenetics in males, each followed by a 6-month, single-blind treatment with Clascoterone solution 75mg BID1 or vehicle BID solution (SCALP 1 and SCALP 2 studies).
The two trials will be conducted in about 60 centers and a total of 1,500 male subjects aged over 18. SCALP 1 with approximately. 750 male subjects will be performed in the US and Georgia and SCALP 2 with approx.
750 male subjects will be perform in the US, Germany and Poland. Co-primary endpoints for both studies are Target Area Hair Count and Patient Reported Outcome. Substantial AGA market with high unmetneeds: Androgenetic Alopecia (AGA), also known as male pattern baldness or female pattern baldness, is a chronic, progressive condition and the most prevalent form of hair loss in both men and women, affecting an estimated 50% of males over 40 years and up to 75% of females over 65 years.
Clascoterone, a new chemical entity, is a topically applied anti-androgen first approved by FDA in August 2020 for the treatment of acne (in a 1% cream) and is now being studied for AGA in a different formulation (s solution) and in a higher strength. Clascoterone is believed to address AGA by directly inhibiting testosterone and dihydrotestosterone binding to local hair follicle androgen receptors. If approved by the FDA, clascoterone solution has the potential to be the only topical androgen receptor inhibitor for AGA and the first drug with a new mechanism of action for the treatment of AGA in nearly three decades.
Clascoterone is quickly metabolised to cortexolone, a metabolite with a known safety profile. Due to its rapid metabolism and local activity, there appears to be limited systemic exposure to clascoterone and therefore potential systemic side effects are likely minimised. Following a successful phase IIa proof of concept trial, a phase II dose-ranging study was conducted in males and results were announced in 2019.
The results showed statistically significant improvement versus vehicle (placebo) for Target Area Hair Count (TAHC) for every dose tested along with directional improvement for Hair Growth Assessment (HGA). The results indicate that clascoterone stops the loss of hair, promotes the growth of new hair, and has a safety profile similar to the vehicle for both adverse events and local skin reactions, even after 12 months treatment.
