Veradermics (MANE) Study result summary

Study design and objectives

• Phase II/III randomized, double-blind, placebo-controlled trial (Study 302) enrolled 519 males aged 18–65 with mild-to-moderate pattern hair loss at 44 US sites, randomized to VDPHL01 8.5mg QD, BID, or placebo for 6 months, followed by a treatment extension period.

• Both once-daily (QD) and twice-daily (BID) oral extended-release minoxidil tablets were tested versus placebo.

• Co-primary endpoints: objective non-vellus hair count (TAHC) and patient-reported outcome (PRO/AAIRS) at Month 6.

• Study population was older and ethnically diverse, with 60% over age 40 and many with cardiac risk factors, mirroring the real-world hair loss population.

• Baseline severity and hair counts were representative of the broader pattern hair loss population.

Efficacy results

• Statistically and clinically significant improvements achieved in both co-primary endpoints for both QD and BID groups, with mean hair count increases of 30.3 (QD) and 33.0 (BID) hairs/cm² vs. 7.3 for placebo at Month 6 (p<0.0001).

• Patient-reported outcomes showed 3.5–4.7x greater benefit over placebo, with 48.4–62.9% reporting 'improved' or 'much improved' hair growth.

• Investigator assessments confirmed 3.7–5.2x more patients with moderate-to-great improvement in active arms versus placebo.

• Rapid onset of effect observed, with significant separation from placebo as early as Month 2.

• Visible regrowth observed in both frontal and vertex scalp, including areas with no current FDA-approved treatments.

Safety and tolerability

• No drug-related or treatment-related serious adverse events (SAEs) or cardiac adverse events of special interest observed.

• Adverse event rates and discontinuations were similar to placebo; most events were mild or moderate and self-resolving.

• No clinically meaningful changes in heart rate, blood pressure, or ECGs; no increase in hair shedding reported.

• Edema and hypertrichosis were the only AEs with >5% imbalance, but led to minimal or no discontinuations.

• Lower discontinuation rates were seen with VDPHL01 compared to placebo.