Cutia Therapeutics has announced positive results from its Phase III clinical trial of CU-40102 (topical finasteride spray) for the treatment of androgenetic alopecia in Chinese male adults. The multi-center, randomized, double-blind, placebo-controlled trial demonstrated statistically significant improvements in hair count compared to placebo after 24 weeks of treatment.
CU-40102 Efficacy and Safety
The Phase III trial enrolled 270 subjects to evaluate the efficacy and safety of CU-40102. The primary efficacy endpoint was the change in total hair count within the targeted bald area at the vertex from baseline in week 24. The results showed that the CU-40102 group had a significantly greater improvement in total hair count and terminal hair count compared to the placebo group (P < 0.05). Efficacy was observed as early as week 12. Investigator assessment scores of the targeted bald area also favored CU-40102 over placebo (P < 0.05).
Safety assessments revealed no treatment-emergent serious adverse events (TESAEs) or treatment-emergent adverse events (TEAEs) leading to death.
CU-30101 for Localized Analgesia
Cutia Therapeutics also presented results from the Phase III clinical trial of CU-30101 (localized topical lidocaine and tetracaine cream) for surface dermatologic operations. This trial was a multi-center, randomized, double-blind study that compared CU-30101 to Pliaglis®. A total of 286 subjects were enrolled, with the primary efficacy endpoint being the Visual Analog Scale (VAS) for immediate pain assessment after fractional laser surgery.
The results indicated that CU-30101 was as effective as Pliaglis® in providing analgesia, achieving the primary endpoint. No statistical differences were observed (P > 0.05) in the evaluation of whether the two studied drugs provided the enrolled subjects with the primary efficacy endpoint of the study.
Regulatory Status
The New Drug Application (NDA) for CU-40102 was accepted by the National Medical Products Administration (NMPA) of China in January 2024.
