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Veradermics Incorporated on Wednesday released topline results from an open-label Phase 2 trial evaluating its experimental VDPHL01 in women with mild-to-moderate pattern hair loss.
The company said the treatment produced consistent hair growth, demonstrated an early onset of activity, and was generally well tolerated, positioning it as a potential first FDA-approved oral therapy for female pattern hair loss.
The Phase 2 Study '207' evaluated VDPHL01 at a 4.5-milligram once-daily dose and a 4.5-milligram twice-daily dose over six months.
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According to the company, participants in both treatment groups experienced clinically meaningful improvements in non-vellus target area hair count.
Women receiving the once-daily regimen recorded an average increase of 22.7 hairs per square centimeter, while those receiving the twice-daily regimen saw an average increase of 23.3 hairs per square centimeter.
The study also met patient-reported outcome measures. By month six, 88.9% of participants in the once-daily arm and 90% in the twice-daily arm rated their hair coverage as "improved" or "much improved" on the Androgenetic Alopecia Impact Rating Scale.
The company said investigators also observed consistent improvements in hair coverage.
At the six-month mark, investigators reported improvement in 100% of participants receiving the once-daily dose and 90% of those receiving the twice-daily regimen.
Evidence of hair growth emerged as early as month two, the first scheduled assessment in the study. At that point, investigators reported improvement in 67.2% of participants, while 63.2% of patients also indicated better hair coverage.
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Veradermics said VDPHL01 maintained a favorable safety profile throughout the study.
The company reported no treatment-related serious adverse events and no adverse events of special interest involving cardiac safety.
The drug candidate is currently being evaluated in a broader pivotal development program targeting both female and male pattern hair loss.
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