VDPHL01, a novel orally-administered extended-release minoxidil formulation, demonstrated Target Area Hair Count (TAHC) deepening in twice-daily (BID) and maintenance in once-daily (QD) treatment arms with increases in non-vellus hair counts of 43.9 hairs/cm 2 (BID) and 29.7 hairs/cm2 (QD) from baseline at Month 12
12-month long-term data demonstrated consistency of hair growth across patient-reported outcomes (PRO) with 89.1% (BID) and 79.8% (QD) reporting visible improvement and 68.0% (BID) and 48.4% (QD) of participants reporting ‘much improved’ or ‘improved’ hair coverage
Favorable 12-month long-term safety and tolerability profile remained consistent with previously reported data, with no new safety signals and no adverse event-related study discontinuations observed after an additional 6 months of treatment
These 12-month long-term results combined with previously reported positive topline findings from Part A of Study ‘302’ and ‘304’ reinforce the potential for VDPHL01 to become the first FDA-approved, non-hormonal, oral treatment for the 50 million men with pattern hair loss in the U.S.
Conference call and webcast scheduled for 8:00 a.m. ET today
Veradermics, Incorporated (NYSE:MANE), a dermatologist-founded, late-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss, today announced positive topline results from Part B of its randomized, double-blind, placebo-controlled, registration-directed Phase 2/3 clinical trial (Study ‘302’) evaluating VDPHL01, an investigational, proprietary, extended-release oral minoxidil formulation, in over 500 males with mild-to-moderate pattern hair loss. These positive results, combined with previously reported positive topline findings from Study ‘302’ Part A and Phase 3 Study ‘304’ Part A, position VDPHL01 to potentially become the first FDA-approved oral pill in nearly 30 years for pattern hair loss and a potential new treatment option for the 50 million men with pattern hair loss in the U.S. To date, data has been reported for more than 1,000 participants in registration-directed studies of VDPHL01 for the treatment of male pattern hair loss.