What is Clascoterone?

Clascoterone [CB-03-01] is a medication that is used topically (applied to the skin) and is primarily prescribed for the treatment of acne. It is a type of anti-androgen, which means it works by decreasing the effects of androgens (male hormones) on the skin. This helps to reduce the production of excess oil and inflammation associated with acne. Clascoterone is typically available as a cream or gel and is applied directly to the affected areas of the skin. Because the androgen DHT dihydrotestosterone is the primary trigger for the miniaturization of hair follicles seen in hereditary hair loss aka Androgenetic Alopecia, there is hope that clascoterone, a topical androgen receptor antagonist, may benefit those suffering from male or female pattern hair loss.

Cosmo Begins Phase III Trials for Male Pattern Hair Loss

Cosmo Pharmaceuticals N.V.

Cosmo announces the beginning of the phase III trials in males for the treatment of androgenetic alopecia

29.06.2023 / 06:15 GMT/BST

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).

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

About the phase III trials and study design
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 17α-Propionate) Solution for the treatment of androgenetic alopecia 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 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”, https://www.delveinsight.com/report-store/androgenetic-alopecia-epidemiology-forecast

If you or someone you know has hair loss, hair thinning, baldness, or eyebrow / eyelash concerns, click to start either a long-distance virtual consultation OR an in-person, in-office consultation with Dr. Bauman. You can also Ask Dr. Bauman a Question or simply call Bauman Medical Group  at +1-561-394-0024.

*Each individual's treatment and/or results may vary

REFERENCES:

Dhillon S. Clascoterone: First Approval. Drugs. 2020 Nov;80(16):1745-1750. doi: 10.1007/s40265-020-01417-6. PMID: 33030710.

Burma NE, Woo TE, Parsons L. Topical Clascoterone for Acne Vulgaris. Skin Therapy Lett. 2022 Jan;27(1):1-3. PMID: 35081302.

Hebert A, Thiboutot D, Stein Gold L, Cartwright M, Gerloni M, Fragasso E, Mazzetti A. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Jun 1;156(6):621-630. doi: 10.1001/jamadermatol.2020.0465. PMID: 32320027; PMCID: PMC7177662.

Manjaly C, Martinez J, Barbieri J, Mostaghimi A. Clascoterone for treatment of acne. Drugs Today (Barc). 2023 Feb;59(2):71-81. doi: 10.1358/dot.2023.59.2.3507749. PMID: 36811407.

Kircik LH. Androgens and acne: perspectives on clascoterone, the first topical androgen receptor antagonist. Expert Opin Pharmacother. 2021 Sep;22(13):1801-1806. doi: 10.1080/14656566.2021.1918100. Epub 2021 Apr 27. PMID: 33906537.