VDPHL01, a novel orally-administered extended-release minoxidil formulation, achieved fast onset of hair growth with the majority of study participants reporting improvement in hair coverage as early as Month 2 and consistent treatment effect with approximately 88.9% (once daily) and 90.0% (twice-daily dosing) of patients reporting ‘improved’ or ‘much improved’ outcomes at Month 6

Robust hair growth was observed with a mean increase in non-vellus target area hair count (TAHC) of 22.7 hairs/cm² and 23.3 hairs/cm² at Month 6, in once and twice daily dosing regimens, respectively

VDPHL01 demonstrated a favorable safety and tolerability profile in females that was generally consistent with prior VDPHL01 trials with no treatment-related SAEs and no AESIs of cardiac origin observed

Veradermics anticipates topline results of ‘Study 306’, a Phase 2/3 clinical trial evaluating VDPHL01 in female pattern hair loss, in 1H 2027

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 its open-label Phase 2 clinical trial (Study ‘207’) evaluating VDPHL01, a proprietary extended-release oral minoxidil formulation, in females with mild-to-moderate pattern hair loss. VDPHL01 has the potential to become the first FDA-approved oral treatment for female pattern hair loss.

Among female participants who received either VDPHL01 4.5mg once daily or VDPHL01 4.5mg twice daily for 6 months, VDPHL01 demonstrated a potentially differentiated clinical profile defined by rapid onset of activity, consistent response across participants, and 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 consistent hair growth on the endpoint of non-vellus TAHC and patient reported outcome (PRO) benefits of ‘improved’ or ‘much improved’ on the Androgenetic Alopecia Impact Rating Scale (AAIRS) at Month 6. Participants achieved an average increase in non-vellus hair count of 22.7 hairs/cm² and 23.3 hairs/ cm² in once daily and twice daily VDPHL01 treatment arms, respectively. Additionally, 88.9% of participants in the once daily dose arm and 90.0% of participants in the twice daily dose arm achieved ‘improved’ or ‘much improved’ hair coverage on the AAIRS.