Veradermics (MANE) Study result summary

Study design and objectives

• Phase 2/3 Study 302 randomized 519 men aged 18–65 with mild-to-moderate pattern hair loss across 44 U.S. sites; Part B followed continued treatment and placebo crossover from months 7–12.

• Part B assessed 12-month safety and durability; Month 12 efficacy was exploratory after the primary six-month efficacy assessment.

Efficacy

• At Month 12, non-vellus hair count increased from baseline by 43.9 hairs/cm² with 8.5 mg BID and 29.7 hairs/cm² with QD; BID was the highest reported Phase 3 program result.

• Hair-count gains appeared by Month 2 and were maintained or deepened through Month 12 with both dosing schedules.

• At Month 12, improved or much-improved coverage was reported by 68.0% of BID and 48.4% of QD participants; any improvement was reported by 89.1% and 79.8%, respectively.

• Investigators rated coverage as improved for 92.2% of BID and 74.4% of QD participants at Month 12.

• After six months of VDPHL01 following placebo, hair counts increased by 32.1 hairs/cm² with BID and 24.5 hairs/cm² with QD; improved or much-improved coverage was reported by 60.7% and 42.9%, respectively.

Safety and tolerability

• Through Month 12, continued treatment showed no treatment-related SAEs, cardiac-origin AESIs, new clinically significant vital-sign or ECG signals, or new peripheral edema cases.

• No AE-related discontinuations or observed shedding were reported in the continued-treatment group; hypertrichosis occurred in 2.1% with QD and 2.8% with BID, with no discontinuations due to it.

• The placebo-crossover group had no treatment-related SAEs, cardiac AESIs, clinically significant heart-rate, blood-pressure or ECG changes, or observed shedding.