Veradermics, Inc. (MANE) announced positive 12-month topline results from Part B of its Phase 2/3 clinical trial (Study ‘302’) for its investigational oral hair loss treatment, VDPHL01. The study, involving over 500 males with mild-to-moderate pattern hair loss, demonstrated sustained efficacy and a favorable long-term safety profile, supporting its potential as a new treatment option.
Key Details
- Primary Efficacy: At 12 months, participants showed an increase in non-vellus hair count of 43.9 hairs/cm² in the twice-daily (BID) group and 29.7 hairs/cm² in the once-daily (QD) group from baseline.
- Patient-Reported Outcomes: Visible improvement in hair coverage was reported by 89.1% of participants in the BID arm and 79.8% in the QD arm. A rating of 'improved' or 'much improved' was given by 68.0% (BID) and 48.4% (QD) of participants.
- Safety Profile: The treatment was generally well tolerated through 12 months, with no new safety signals observed. There were no treatment-related serious adverse events and no discontinuations due to adverse events between months 6 and 12.
- Drug Information: VDPHL01 is an investigational, proprietary, extended-release oral minoxidil formulation being developed for male and female pattern hair loss.