en.Wedoany.com Reported - Dayspring Pharma announced positive top-line results from its Phase II clinical trial of the candidate drug CG2001 at the 14th World Congress for Hair Research. The results were presented orally by Professor Zhou Cheng, Director of the Dermatology Department at Peking University People's Hospital, during the meeting held in Seoul, South Korea. CG2001 is a topical fixed-dose combination formulation containing minoxidil and finasteride, intended for the treatment of male androgenetic alopecia.
This randomized, double-blind, placebo-controlled trial included multiple treatment groups: CG2001 (5% minoxidil and 0.075% finasteride) once daily, CG2001 (5% minoxidil and 0.1% finasteride) once daily, CG2001 (5% minoxidil and 0.075% finasteride) twice daily, and a control group. The study showed that at Week 24, the CG2001 (5% minoxidil and 0.075% finasteride) twice-daily group demonstrated a statistically significant improvement in the change from baseline in target area hair count (TAHC) compared to the placebo group, meeting the primary endpoint. Additionally, all treatment groups exhibited good safety and tolerability.
Key top-line data showed that the CG2001 (5% minoxidil and 0.075% finasteride) twice-daily group achieved a TAHC increase of 28.17 hairs/cm² from baseline at Week 24 (p=0.006), compared to an increase of 7.68 hairs/cm² in the placebo group. In this treatment group, a sustained trend of TAHC growth was observed at Weeks 6, 12, 18, and 24, along with an improvement trend in subject self-assessment. CG2001 was generally well tolerated across all treatment groups, with no sex-related adverse events reported, and all adverse events were mild to moderate in severity.
Yu Baohui, CEO of Dayspring Pharma, stated that despite existing approved treatments, there remains a significant unmet clinical need in the field of androgenetic alopecia. The Phase II results support the potential of CG2001 as a differentiated treatment option and its continued clinical development. The company is currently in communication with regulatory authorities to determine the next phase of the clinical development plan.
CG2001 utilizes a specially designed foam formulation containing optimized dose ratios of minoxidil and finasteride, aiming to leverage the synergistic potential of the two foundational therapies. Minoxidil promotes hair growth, while finasteride reduces dihydrotestosterone levels by inhibiting 5α-reductase. The drug improves topical follicular delivery through an optimized delivery system, aiming to enhance efficacy and reduce systemic exposure associated with oral finasteride.
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