Veradermics to Hold Conference Call to Discuss Topline Results from Phase 3 ‘304’ Clinical Trial of VDPHL01 in Males with Mild-to-Moderate Pattern Hair Loss
Conference call will take place on
Webcast Details:
The event and the accompanying slides will be available on the Events page in the Investors section of the company’s website. A replay will be available following the call.
About VDPHL01
VDPHL01 (extended-release minoxidil tablet) is a proprietary investigational, oral non-hormonal drug in Phase 3 development for pattern hair loss in both women and men. VDPHL01 leverages extended-release technology to deliver a minoxidil product with the potential for improved efficacy and safety. The proprietary extended-release formulation utilizes a gel matrix designed to deliver long-lasting, steady release of minoxidil for sustained absorption. VDPHL01 has been shown to avoid the high peak concentrations of immediate-release oral minoxidil, while extending time above the minimum hair growth threshold to increase time for hair to grow. If approved, VDPHL01 would be the only
About the VDPHL01 Registration-Directed Clinical Development Program
The registration-directed clinical development program for VDPHL01 comprises three multicenter, randomized, double-blind, placebo-controlled trials that together enrolled more than 1,600 adult men and women with mild-to-moderate pattern hair loss.
Each trial employs a 52-week design consisting of a six-month placebo-controlled period followed by a six-month extension in which all participants receive VDPHL01. Each trial has the same co-primary endpoints at Month 6: change from baseline in non-vellus target area hair count (TAHC), and the proportion of participants reporting “improved” or “much improved” hair coverage on the Androgenetic Alopecia Impact Rating Scale (AAIRS). Studies ‘302’ and ‘306’ include a Phase 2 component to further assess the proprietary patient-reported outcome (PRO) measures used across the program.
These trials are designed to support the potential
- Study ‘302’ (NCT06724614): Phase 2/3 trial of VDPHL01 8.5 mg once and twice daily in 519 men.
- Study ‘304’ (NCT06972264): Phase 3 trial of VDPHL01 8.5 mg once and twice daily in 536 men.
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Study ‘306’ (NCT07146022): Phase 2/3 trial of VDPHL01 4.5 mg once and twice daily in 556 women. It is the first registration-directed trial of an oral therapy specifically for female pattern hair loss in the
U.S .
The program builds on earlier clinical studies of VDPHL01, including Study ‘207,’ an open-label Phase 2 proof-of-concept trial in men and women with pattern hair loss, and a Phase 1 pharmacokinetic study.
About Pattern Hair Loss
Pattern hair loss, also known as androgenetic alopecia, affects an estimated 80 million people in
About Veradermics, Inc.
Veradermics is a dermatologist-founded, late clinical-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss. Veradermics aims to develop a focused portfolio of aesthetic dermatology product candidates targeting high-prevalence dermatologic conditions, with potential selective development of medical dermatology product candidates. Its lead program, VDPHL01, is being developed as an oral, non-hormonal treatment for men and women with pattern hair loss, to reduce the barriers to wide adoption of chronic hair loss therapy and potentially transform pattern hair loss treatment. VDPHL01 is an oral, extended-release proprietary formulation of minoxidil, a proven hair growth agent, designed to maximize minoxidil’s impact on hair restoration while minimizing the risk of cardiac activity. For additional information, visit www.veradermics.com and follow us on LinkedIn and Instagram.
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Media:
Catherine Collier Kyroulis
917-886-5586
media@veradermics.com
Investors:
investors@veradermics.com
Source: Veradermics, Incorporated