Veradermics scores another late-stage trial win for hair loss therapy

Veradermics (MANE) gained in early premarket trading on Monday after announcing that another late-stage trial for its lead asset, VDPHL01, met all primary and secondary endpoints in patients with pattern hair loss, also known as androgenetic alopecia.

Based on topline data, the New Haven, Connecticut, headquarters firm said that the once-daily (QD) and twice-daily (BID) versions of the pill succeeded in its Phase 3 study '304, which enrolled 536 subjects with mild-to-moderate pattern hair loss.

According to the company, once daily and twice daily VDPHL01 led to a target area hair count (TAHC) of 28.6 hairs/cm² and 36.4 hairs/cm², respectively, consistent with findings from its Phase 2/3 Study '302, which also met all primary and secondary endpoints in April.

Meanwhile, 78.8% and 85% on QD and BID dosing regimens recorded participant-reported visible improvement in patient-reported outcomes, respectively, compared with 35.3% of placebo recipients.

There were no new safety events, and VDPHL01 showed a favorable safety and tolerability profile in more than 1,000 subjects who participated across both registrational studies, according to Veradermics (MANE).

Part A of Study ‘302 and Study ‘302’ have therefore generated the full placebo-controlled data set required to support the FDA approval of the first non-hormonal oral medicine in the U.S. for pattern hair loss, the company added.