Veradermics, Inc. (MANE) announced positive topline data from its Phase 3 clinical trial, Study ‘304’, for VDPHL01, a proprietary oral extended-release minoxidil formulation for males with mild-to-moderate pattern hair loss. The trial met all primary and secondary endpoints with high statistical significance and demonstrated a favorable safety profile, positioning the drug as a potential first-in-class, FDA-approved non-hormonal oral treatment for the condition.
Key Details
- Trial Overview: The study enrolled 536 male patients who were randomized to receive VDPHL01 once-daily (QD), twice-daily (BID), or a placebo over a 6-month period.
- Efficacy Endpoints: Patients on VDPHL01 showed an average hair count increase of 28.6 hairs/cm² (QD) and 36.4 hairs/cm² (BID), significantly outperforming the 6.6 hairs/cm² increase in the placebo group (p<0.0001).
- Patient-Reported Outcomes: 55.7% (QD) and 68.7% (BID) of patients reported 'improved' or 'much improved' hair coverage, compared to 15.0% of patients receiving the placebo.
- Safety Profile: The treatment was generally well-tolerated, with no treatment-related serious adverse events or adverse events of special interest of cardiac origin observed during the study.