Veradermics, Incorporated (NYSE: MANE) announced positive topline results from Part B of its Phase 2/3 clinical trial, Study '302', evaluating VDPHL01 in males with mild-to-moderate pattern hair loss. The study enrolled 519 patients who were randomized to receive VDPHL01 8.5mg once daily (QD), VDPHL01 8.5mg twice daily (BID), or placebo for six months, followed by a crossover period where placebo patients received active treatment for an additional six months.
According to the filing, participants in the VDPHL01 continued group experienced an increase in non-vellus hair count of 43.9 hairs/cm² in the twice-daily arm and 29.7 hairs/cm² in the once-daily arm from baseline to Month 12. The data demonstrated a deepening of hair growth in the BID dose arm and maintenance of hair growth in the QD dose arm. Patient-reported outcomes showed that 89.1% of participants in the BID arm and 79.8% in the QD arm reported visible improvement in hair coverage on the Androgenetic Alopecia Impact Rating Scale (AAIRS) at Month 12.
Investigator assessments also supported these findings, grading 92.2% of BID participants and 74.4% of QD participants as having improved hair coverage using the Investigator Global Assessment (IGA) scale. The safety profile remained consistent with previous studies, with no treatment-related serious adverse events, no cardiac adverse events of special interest, and no new safety signals observed through Month 12.
Participants in the placebo crossover group also achieved clinically meaningful results, with increases in non-vellus hair count of 32.1 hairs/cm² (BID) and 24.5 hairs/cm² (QD) at Month 12. The company noted that these results, combined with data from Study '304', position VDPHL01 to potentially become the first FDA-approved oral non-hormonal treatment for pattern hair loss in the United States.
