Full story: https://grafa.com/en/news/united-states/veradermics-vdphl01-phase-3-hair-growth-study-304
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Veradermics reported that its investigational hair loss treatment, VDPHL01, met all primary and secondary endpoints in the Phase 3 Study 304 trial involving 536 men.
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Average hair counts increased by 28.6 hairs/cm² with once-daily treatment and 36.4 hairs/cm² with twice-daily treatment, compared with 6.6 hairs/cm² for placebo.
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The company said positive results from Studies 302 and 304 support its pursuit of FDA approval for VDPHL01, although the treatment remains investigational.
Veradermics (NYSE:MANE) reported positive Phase 3 results for VDPHL01, with both dosing regimens significantly increasing hair counts versus placebo after six months.
Average increases reached 28.6 hairs/cm² with once-daily treatment and 36.4 with twice-daily dosing, compared with 6.6 for placebo.
Both regimens met the study's patient-reported outcome endpoint, with 55.7% and 68.7% reporting improved or much-improved coverage versus 15% on placebo.
The 536-participant trial showed statistically significant improvements by Month 2, with no treatment-related serious adverse events or cardiac events of special interest.
Veradermics plans to use results from Studies 302 and 304 to support potential FDA approval, although VDPHL01 remains investigational.
The company reported peripheral edema in 2.8% and 4.5% of once-daily and twice-daily recipients, respectively, versus 0.6% on placebo.
VDPHL01 is an extended-release oral minoxidil formulation, with Veradermics also conducting a separate Phase 2/3 trial evaluating treatment for female pattern hair loss.
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