Dermatology therapy developer Cutia Therapeutics (HKG: 2487) has announced that its Phase III clinical study for CU-40102 (external einasteride spray) in androgenic alopecia in China has successfully reached its primary endpoint.
Study Design and Patient Enrollment
The multi-center, randomized, double-blind, placebo-controlled Phase III regulatory study was designed to assess the efficacy and safety of CU-40102 in Chinese male patients with androgenic alopecia. A total of 270 Chinese adult male subjects with androgenic alopecia were enrolled, with 180 assigned to the CU-40102 group and 90 to the placebo group. The subjects received topical medication once a day on the scalp during the 24-week continuous treatment period.
Efficacy and Safety Results
The results demonstrated that after 24 weeks of treatment, the total hair count and final hair count in the target area of top baldness in the CU-40102 group were significantly improved compared to the placebo group, meeting both the primary and secondary endpoints. Efficacy began to show from week 12. In terms of safety, CU-40102 subjects showed good local tolerance to the administration site, and the overall incidence of adverse events was similar between the CU-40102 group and the placebo group.
Consistency with Overseas Trials and Pharmacokinetic Study
The results are consistent with those of trials carried out overseas. Concurrently, a Phase I pharmacokinetic study of CU-40102 in Chinese adult male androgen alopecia patients showed that after the administration of einasteride spray, the systemic absorption was very little, indicating a low systemic exposure to the drug.
CU-40102: A Novel Approach to Treating Androgenic Alopecia
CU-40102 is described as the world’s first and currently only of its kind approved for trials, with einasteride as a specific type II 5 α-reductase competitive inhibitor that inhibits the conversion of testosterone into dihydrotestosterone in the scalp, treating androgenic alopecia in male patients. Unlike oral einasteride, the topical formulation of CU-40102 allows patients to apply the drug directly and accurately to the scalp surface, maintaining a high concentration at the medication site, reducing systemic exposure to the drug, and potentially reducing the side effects often caused by oral administration.-Fineline Info & Tech
