On Monday, Veradermics Incorporated (NYSE:MANE) announced positive topline results from Part A of its registration-directed Phase 3 trial evaluating an experimental oral hair loss medication.
Following the announcement, the stock jumped more than 10%.
The dermatologist-founded biopharmaceutical firm tested VDPHL01, a proprietary extended-release oral minoxidil formulation, in 536 men with mild-to-moderate pattern hair loss.
The Study ‘304’ met all primary and secondary endpoints with high statistical significance.
The company said these results combined with previously reported positive topline findings from Part A of the Phase 2/3 trial represent the full placebo-controlled data set to support the potential for VDPHL01 to become the first FDA-approved non-hormonal oral treatment for the 50 million men with pattern hair loss in the U.S.
Statistically Significant Hair Growth Across Both Doses
Participants received either an 8.5-milligram dose once daily, an 8.5-milligram dose twice daily, or a placebo. Over six months, active treatment arms demonstrated substantial increases in hair count alongside rapid onset of efficacy visible as early as Month 2.
At Month 6, patients achieved an average increase in non-vellus hair count of 28.6 hairs per square centimeter in the once-daily cohort and 36.4 hairs per square centimeter in the twice-daily cohort, compared to 6.6 hairs per square centimeter for placebo.
On the Androgenetic Alopecia Impact Rating Scale, 78.8% of once-daily patients and 85.0% of twice-daily patients noted improved hair coverage, versus 35.3% on placebo.
Furthermore, 55.7% of once-daily participants and 68.7% of twice-daily participants reported being ‘improved’ or ‘much improved,’ compared to 15.0% of the placebo group.
Clinicians corroborated these findings via the Investigator Global Assessment scale, noting improvements in 78.4% of once-daily and 82.7% of twice-daily participants.
CEO Reid Waldman said the combined results from more than 1,000 participants demonstrated meaningful hair growth with an encouraging safety profile.
Clean Safety Profile and Upcoming Clinical Readouts
VDPHL01 proved generally well tolerated across both active arms. Investigators observed no treatment-related serious adverse events and no cardiac-related adverse events of special interest.
Veradermics expects to report data from Part B of Study ‘302’ later this year. The company also finished enrollment in August for Study ‘306’, a Phase 2/3 trial in female pattern hair loss, with topline results projected in the first half of 2027.
Veradermics Price Action
MANE Price Action: Veradermics shares were up 10.11% at $119.82 at the time of publication on Monday, according to Benzinga Pro data.
Photo via Shutterstock
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