Veradermics announces VDPHL01 met all primary, secondary endpoints

Veradermics (MANE) announced positive topline results from Part A of its randomized, double-blind, placebo-controlled Phase 2/3 clinical trial evaluating VDPHL01, a proprietary extended-release oral minoxidil formulation, in over 500 males with mild-to-moderate pattern hair loss. Veradermics believes these results position VDPHL01 to potentially become the first FDA-approved oral pill in nearly 30 years for pattern hair loss and a potential best-in-indication treatment option for the 50 million men with pattern hair loss in the U.S. Key data: VDPHL0 met all primary and all key secondary endpoints with high statistical significance in both active treatment arms evaluating once-daily and twice-daily administration of VDPHL01; Rapid and robust hair growth was achieved with VDPHL01 treatment as demonstrated by a mean increase in non-vellus target area hair count of 30.3 hairs/cm2 and 33.0 hairs/cm2 versus 7.3 hairs/cm2 for placebo at Month 6; Approximately 79.3% and 86.0% of patients reported any improvement in patient-reported outcomes versus 35.6% of placebo patients; 48.4% and 62.9% of patients reported ‘improved’ or ‘much improved’ outcomes at Month 6 versus 13.4% of placebo patients; Statistically significant improvement in hair growth was observed at Month 2, the earliest time point evaluated