Veradermics Reports Phase 2/3 Data For VDPHL01; Shows Significant Hair Growth Gains (30-33 hairs/cm²) And Strong Efficacy Vs Placebo In Pattern Hair Loss Treatment

VDPHL01, a novel orally-administered extended-release minoxidil formulation, met all primary and all key secondary endpoints with high statistical significance in both active treatment arms evaluating once-daily (QD) and twice-daily (BID) administration of VDPHL01

Rapid and robust hair growth was achieved with VDPHL01 treatment as demonstrated by a mean increase in non-vellus target area hair count (TAHC) of 30.3 hairs/cm² (once daily dosing; p<0.0001) and 33.0 hairs/cm² (twice daily dosing; p<0.0001) versus 7.3 hairs/cm² for placebo at Month 6

Approximately 79.3% (QD) and 86.0% (BID) of patients reported any improvement in patient-reported outcomes (PRO) versus 35.6% of placebo patients; 48.4% (QD; p<0.0001) and 62.9% (BID; p<0.0001) of patients reported ‘improved' or ‘much improved' outcomes at Month 6 versus 13.4% of placebo patients

Statistically significant improvement in hair growth was observed at Month 2, the earliest time point evaluated

VDPHL01 demonstrated a favorable safety and tolerability profile with overall adverse event rates similar to placebo

VDPHL01 has the potential to become the first FDA-approved non-hormonal oral treatment for the approximately 80 million men and women with pattern hair loss in the U.S.

Conference call and webcast scheduled for 8:00 a.m. ET today

Veradermics, Incorporated (NYSE:MANE), a dermatologist-founded, late-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss, today announced positive topline results from Part A of its randomized, double-blind, placebo-controlled Phase 2/3 clinical trial (Study ‘302') evaluating VDPHL01, a proprietary extended-release oral minoxidil formulation, in over 500 males with mild-to-moderate pattern hair loss. Veradermics believes these results position VDPHL01 to potentially become the first FDA-approved oral pill in nearly 30 years for pattern hair loss and a potential best-in-indication treatment option for the 50 million men with pattern hair loss in the U.S.

Study ‘302' enrolled 519 patients who were randomized to receive either VDPHL01 8.5mg once daily (QD), VDPHL01 8.5mg twice daily (BID), or placebo. The trial met all primary and all key secondary endpoints with statistical significance, demonstrating a potentially differentiated clinical profile defined by rapid onset of activity, consistent response across patients, and robust increases in hair count while being generally well tolerated with no treatment-related serious adverse events (SAEs) and no adverse events of special interest (AESIs) of cardiac origin.

In the study, VDPHL01 achieved superior hair growth compared with placebo (p<0.0001) on the co‑primary endpoints of non-vellus Target Area Hair Count (TAHC) and patient reported outcome (PRO) benefit of ‘improved' or ‘much improved' on the Androgenetic Alopecia Impact Rating Scale (AAIRS) at Month 6. Patients achieved an average increase in non-vellus hair count of 30.3 hairs/cm² (p<0.0001) and 33.0 hairs/cm² (p<0.0001) in once daily and twice daily VDPHL01 treatment arms, respectively. Those receiving placebo only showed a 7.3 hairs/cm² increase from baseline at Month 6.

Following 6 months of treatment with VDPHL01, 79.3% of patients in the once daily dose arm (p<0.0001) and 86.0% of patients in the twice daily dose arm (p<0.0001) reported improvement in hair coverage on the AAIRS versus 35.6% of placebo patients. Additionally, 48.4% of patients in the once daily dose arm (p<0.0001) and 62.9% of patients in the twice daily dose arm (p<0.0001) achieved ‘improved' or ‘much improved' hair coverage on the AAIRS compared to only 13.4% of placebo patients.