Veradermics (NYSE:MANE) reported positive top-line results from Part A of Study 304, its second Phase III trial of VDPHL01, an extended-release oral minoxidil tablet being developed for men with mild to moderate pattern hair loss.
The randomized, double-blind, placebo-controlled study enrolled 536 male participants ages 18 to 65 at 45 U.S. sites that did not overlap with the company’s prior Study 302. Participants received VDPHL01 at 8.5 mg once daily, 8.5 mg twice daily, or placebo during the six-month placebo-controlled period.
Co-Primary Endpoints Met
Chief Executive Officer Reid Waldman said Study 304 achieved statistically significant separation from placebo on both co-primary endpoints and all 17 secondary endpoints. The co-primary measures were target-area non-vellus hair count and a patient-reported assessment of visible hair coverage improvement.
At six months, the once-daily group recorded an increase of 28.6 non-vellus hairs in the target area from baseline, while the twice-daily group recorded an increase of 36.4 hairs. Waldman said the twice-daily result was the largest six-month change reported in a placebo-controlled pattern hair loss study to date.
More than half of patients receiving the once-daily regimen and nearly 70% receiving the twice-daily regimen rated their hair coverage as improved or much improved, compared with 15% of placebo recipients. The company said nearly 80% of once-daily patients and more than 80% of twice-daily patients reported any improvement in hair coverage.
According to Waldman, VDPHL01 separated from placebo as early as month two on patient-reported outcomes, hair counts and investigator global assessments, the earliest time point evaluated.
Frontal Hair and Safety Findings
Study 304 also included an independent frontal photograph review, in which three blinded reviewers assessed changes in frontal scalp photographs. More than one-third of once-daily patients and nearly half of twice-daily patients met the responder definition, versus 5% of placebo patients.
Waldman said the result supports a potential benefit in frontal hair loss, an area for which he said no current treatment is labeled. He noted that frontal hair loss is often among the earliest and most visible manifestations of male pattern hair loss.
The company reported no treatment-related serious adverse events and no cardiac adverse events of special interest, including pericardial effusion, pleural effusion, heart failure or angina. Veradermics also reported no clinically meaningful changes in heart rate, blood pressure or ECGs.
Adverse events were primarily mild to moderate and often resolved on their own, according to the company. Hypertrichosis was the only event occurring in more than 5% of patients with an imbalance between active treatment and placebo. Across Studies 302 and 304, one patient discontinued due to hypertrichosis, while five of more than 700 treated patients discontinued due to peripheral edema, Waldman said.
Michael Payette, co-founder of Central Connecticut Dermatology, said the patient-reported outcomes were particularly meaningful from a clinical perspective. He said immediate-release oral minoxidil can be disappointing in practice, with many patients failing to see the level or speed of improvement they expect. Payette also said the absence of reported post-treatment shedding in the trials could be significant, as shedding after initiating immediate-release minoxidil can lead patients to stop treatment.
Development and Commercial Outlook
Study 304 completes Veradermics’ planned placebo-controlled development program for VDPHL01 in male pattern hair loss. Combined with the company’s earlier Study 302, the Phase III male program includes more than 1,000 participants.
Veradermics expects extension data from Study 302 later this year. Its Study 306, which enrolled 556 females and is evaluating VDPHL01 in female pattern hair loss, is fully enrolled, with Part A results expected in the first half of 2027. Waldman said the company is still determining whether it will pursue a regulatory filing in men alone or in men and women together.
Chief Commercial and Strategy Officer Mark Neumann presented results from market research involving 198 dermatologists and primary care providers who see meaningful numbers of pattern hair loss patients but have been hesitant to prescribe existing treatments. Nearly 90% of surveyed clinicians rated VDPHL01 as positively differentiated after reviewing the Phase III profile, and about two-thirds said they would use it as a first-line or go-to treatment if approved.
Neumann said survey respondents expected prescription treatment use among their pattern hair loss patients could rise from roughly one-third to two-thirds with VDPHL01 available. He also said clinicians surveyed expected VDPHL01’s perceived efficacy, safety and FDA-approved status to support use despite a potential premium price relative to generic immediate-release oral minoxidil.
Veradermics said it had approximately $820 million on its balance sheet as of its most recent quarterly earnings report.
About Veradermics (NYSE:MANE)
Veradermics, Inc is a clinical-stage biopharmaceutical company focused on developing therapies for dermatologic diseases. The company’s research and development efforts are aimed at addressing conditions that affect the skin, hair and nails, with an emphasis on treatments designed to improve patient outcomes and quality of life.
Veradermics is advancing a pipeline of investigational dermatology products across multiple disease areas. Its activities include the discovery, clinical development and potential commercialization of prescription therapies for conditions with unmet medical needs.
