Veradermics shares rose after the company said it saw positive top-line results from Part A of its placebo-controlled registration-directed Phase 3 clinical trial evaluating VDPHL01, a proprietary, extended-release oral minoxidil formulation, in more than 500 males with mild-to-moderate pattern hair loss.
The stock was 7.4% higher, at $116.90, in morning trade.
The biopharmaceutical company said these positive registration-directed results, combined with previously reported positive top-line findings from Part A of its Phase 2/3 clinical trial, position VDPHL01 to potentially become the first FDA-approved oral pill in nearly 30 years for pattern hair loss.
To date, the company said, six-month placebo-controlled data has been reported for more than 1,000 participants in registration-directed studies of VDPHL01 for the treatment of male pattern hair loss.
The most recent study enrolled 536 participants who were randomized to receive either VDPHL01 8.5mg once daily, VDPHL01 8.5mg twice daily, or a placebo.
The trial met all primary and secondary endpoints with high statistical significance, demonstrating a potentially differentiated clinical profile defined by rapid onset of activity, consistent response across participants, and robust increases in hair count, the company said.
Veradermics said the trial was generally well tolerated with no treatment-related serious adverse events and no adverse events of special interest of cardiac origin.
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