VDPHL01 meets Phase 3 endpoints in male pattern hair loss trial

Veradermics, Incorporated (NYSE: MANE) reported that VDPHL01 met all primary and secondary endpoints in its Phase 3 clinical trial, Study ‘304’, for male pattern hair loss. The company stated that the orally administered extended-release minoxidil formulation demonstrated high statistical significance across both active treatment arms.

In Study ‘304’, which enrolled 536 participants with mild-to-moderate pattern hair loss, VDPHL01 demonstrated superior hair growth compared to placebo at Month 6. Participants in the once-daily dosing arm achieved an average increase in non-vellus Target Area Hair Count (TAHC) of 28.6 hairs/cm², while those in the twice-daily arm saw an increase of 36.4 hairs/cm², both with p-values less than 0.0001. The placebo group showed a mean increase of 6.6 hairs/cm² over the same period. These figures align with previously reported topline data from Part A of Study ‘302’, where increases of 30.3 hairs/cm² and 33.0 hairs/cm² were observed for the once-daily and twice-daily arms, respectively.

Patient-reported outcomes on the Androgenetic Alopecia Impact Rating Scale (AAIRS) indicated that 78.8% of participants in the once-daily arm and 85.0% in the twice-daily arm reported visible improvement in hair coverage versus 35.3% of placebo participants. Furthermore, 55.7% and 68.7% of treated participants, respectively, rated their outcomes as ‘improved’ or ‘much improved,’ compared to 15.0% of those on placebo. Investigator Global Assessments corroborated these findings, with investigators grading 78.4% and 82.7% of treated participants as having improved hair coverage at Month 6.

The trial also indicated a rapid onset of activity, with statistically significant separation from placebo observed as early as Month 2 across TAHC, patient-reported outcomes, and investigator assessments. Veradermics reported that VDPHL01 maintained a favorable safety profile in Study ‘304’, with no treatment-related serious adverse events or adverse events of special interest of cardiac origin observed through Month 6. The most common treatment-emergent adverse events occurring in more than 5% of participants in either trial were peripheral edema and hypertrichosis.

Reid Waldman, M.D., Chief Executive Officer of Veradermics, stated that the combined data from more than 1,000 participants across the two registration-directed studies support the potential for VDPHL01 to become the first FDA-approved non-hormonal oral treatment for pattern hair loss in the United States. The company anticipates reporting longer-term safety data from Part B of Study ‘302’ later this year, extending observations through 12 months.