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.
Novartis secures European approval for remibrutinib in chronic spontaneous urticaria
GSK secures US and EU fast-track designations for efimosfermin in MASH
Veradermics reports positive Phase 2/3 results for oral VDPHL01 in pattern hair loss treatment
Cantargia reports early remission data from nadunolimab trial in MDS and AML
AOTI reports strong real-world outcomes for TWO2 wound therapy
Ascletis completes enrolment for US Phase II study of ASC30 in diabetes