Veradermics, Incorporated (MANE), a late-stage biopharmaceutical company, on Monday reported positive topline results in the Phase 2/3 trial for VDPHL01, an oral formulation of minoxidil for treating male pattern hair loss.
Following the news, shares are up over 20% in the premarket.
Pattern hair loss affects nearly 80 million individuals in the U.S. alone, including 30 million women and 50 million men.
The extended-release minoxidil drug VDPH01 is a proprietary, investigational, orally available, non-hormonal drug developed for the treatment of androgenetic alopecia. It could be the first prescription for the treatment of hair loss if approved by the U.S. Food and Drug Administration (FDA) in 30 years, and the only oral, non-hormonal drug for pattern hair loss to potentially receive FDA approval.
VDPH01 was evaluated in the pivotal double-blind, randomized, placebo-controlled Phase 2/3 Part A trial, or Study '302', conducted over 6 months with 519 patients.
The drug met all primary endpoints, showing clinically meaningful and statistically significant increases in non-vellus Target Area Hair Count (TAHC), and a patient-reported outcome (PRO) of 'improved' or 'much improved' on the Androgenetic Alopecia Impact Rating Scale (AAIRS) at Month 6. VDPHL01 showed a robust hair count increase and was generally well-tolerated, with no adverse side effects recorded.
The company announced completion of enrolment in Phase 3 or Study '304' for VDPHL01, topline results of which are expected in the second half of this year. Recruitment is ongoing for the Phase 2/3 trial or Study '306' to determine the efficacy of VDPHL01 in female patients.
MANE closed Friday at $67.84, down 2.04%. In the premarket, the stock is trading at $84.50, up 24.76%.
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