Veradermics (MANE) Study result summary

Study design and endpoints

• Phase 3 Study 304 randomized 536 men aged 18–65 with mild-to-moderate pattern hair loss at 45 U.S. sites to VDPHL01 8.5 mg once daily, twice daily, or placebo.

• Study 304 met its co-primary and all 17 secondary endpoints at Month 6; TAHC, patient-reported hair coverage and investigator assessments separated from placebo by Month 2.

• Studies 302 and 304 evaluated more than 1,000 subjects combined, completing planned placebo-controlled development in males.

Efficacy results

• Month 6 non-vellus TAHC gains were 28.6 hairs/cm² with once-daily and 36.4 hairs/cm² with twice-daily dosing, versus 6.6 with placebo; both active arms p<0.0001.

• Hair coverage improved or much improved for 55.7% of once-daily and 68.7% of twice-daily participants, versus 15.0% with placebo; any improvement was reported by 78.8%, 85.0% and 35.3%, respectively.

• Independent frontal-photo responders exceeded one-third with once-daily and neared half with twice-daily dosing, versus 5% with placebo.

• Investigators rated coverage improved for 78.4% of once-daily and 82.7% of twice-daily participants at Month 6.

• Study 302 hair-count gains were 30.3 hairs/cm² with once-daily and 33.0 with twice-daily dosing, versus 7.3 with placebo.

Safety and tolerability

• No treatment-related serious adverse events or cardiac adverse events of special interest occurred in Study 304; no clinically meaningful heart-rate, blood-pressure or ECG changes were observed.

• Adverse events were mostly mild to moderate; hypertrichosis was the only event occurring in more than 5% with an active-versus-placebo imbalance.

• Across studies, one treated subject discontinued for hypertrichosis, peripheral-edema discontinuations were below 1% for both regimens, and no post-treatment-initiation shedding was reported.