Veradermics Inc (NYSE:MANE), a late-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss, on Monday announced positive topline results from its Phase 2/3 Study '302' evaluating oral VDPHL01 in over 500 males with mild-to-moderate pattern hair loss.
The trial enrolled 519 patients and assessed once-daily and twice-daily dosing versus placebo.
VDPHL01, an extended-release oral minoxidil formulation, met all primary and key secondary endpoints with statistical significance at Month 6. Patients achieved mean increases in non-vellus target area hair count of 30.3 hairs/cm2 (once daily) and 33.0 hairs/cm2 (twice daily), compared with 7.3 hairs/cm2 for placebo.
Patient-reported outcomes showed improvement in 79.3% of once-daily patients and 86.0% of twice-daily patients versus 35.6% for placebo, with rapid separation from placebo observed as early as Month 2. Investigator assessments also indicated improved hair coverage in 72.0% (QD) and 84.4% (BID) of treated patients.
The study showed a favourable safety profile, with adverse event rates similar to placebo and no treatment-related serious adverse events or cardiac-related events observed. Discontinuation rates were comparable between active treatment and placebo arms.
Veradermics said that Study '302' is part of a broader development programme supporting potential approvals in both male and female pattern hair loss, with additional Phase 3 data expected in the second half of 2026.
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