|
Cosmo Pharmaceuticals N.V.
/ Key word(s): Study
Dublin, Ireland – June 29, 2023: Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (“Cosmo”) today announced the beginning of the phase III trials of clascoterone solution in males for the treatment of androgenetic alopecia (AGA).
About the phase III trials and study design
The two trials will be conducted in about 60 centers and a total of 1,500 male subjects aged over 18. SCALP 1 with approx. 750 male subjects will be performed in the US and Georgia and SCALP 2 with approx. 750 male subjects will be performed in the US, Germany and Poland.
Co-primary endpoints for both studies are Target Area Hair Count (TAHC) and Patient Reported Outcome (PRO). Substantial AGA market with high unmet needs 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. Characterized by a defined hair loss pattern in both sexes, genetics plays a strong role in its etiology. Genetic variations in the human androgen receptor (AR) gene may trigger early-onset AGA and the extent to which these receptors respond to dihydrotestosterone (DHT) is also genetically influenced. However, early treatment targeting DHT’s interaction with AR may reverse or temper the effects of DHT on hair loss.
In AGA, high local DHT concentrations bind to the androgen receptors within the scalp hair follicles, resulting in shortening of the hair cycle and gradual miniaturization of the scalp follicles. Over time, these progressively smaller, thinner hair follicles are unable to produce new hair, thus resulting in AGA’s characteristic patterned baldness. DHT dependent effects are considered, in most cases, reversible, and may be responsive to medical treatment with androgen receptor inhibitor drugs such as clascoterone.
It is estimated that 194 million2 patients in seven major markets (US, France, Germany, Italy, Spain, UK, and Japan) are affected by AGA, of which over 80 million in the US alone. Hair loss is often a cause of great concern to affected subjects for cosmetic and psychological reasons. Most AGA sufferers may not seek treatment likely due to limitations of current treatments and lack of available options. A new therapeutic drug option indicated for AGA has not been introduced for nearly 30 years.
Diana Harbort, President of Cosmo’s Dermatology Division, said: “We are pleased to finally have the first patient recruited in this key phase III program. The global hair loss market is very large and very underserved with only OTC products and generic therapies available. Therefore, our product, if approved, could serve a substantial global audience and improve the life of many people suffering from hair loss.”
1 BID = bis in die / twice a day 2 DelveInsight’s “Androgenetic Alopecia – Epidemiology Forecast – 2032”,
About Clascoterone solution 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 (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.
Disclaimer Contact:
End of Media Release |
| Language: | English |
| Company: | Cosmo Pharmaceuticals N.V. |
| Riverside 2, Sir John Rogerson’s | |
| Dublin 2 Dublin | |
| Ireland | |
| Phone: | 0 |
| E-mail: | |
| Internet: | / |
| ISIN: | NL0011832936 |
| Listed: | SIX Swiss Exchange |
| EQS News ID: | 1668323 |
| End of News | EQS News Service |
|
|
1668323 29.06.2023 GMT/BST
