Veradermics, a pharma company focused on developing innovative therapeutics for pattern hair loss, has announced positive phase 3 results for its oral minoxidil formulation for mild-to-moderate pattern hair loss.
Study ‘304’ evaluated VDPHL01, a proprietary, extended-release oral minoxidil formulation, in over 500 males.
The positive results, combined with previously reported positive topline findings from the company’s phase 2/3 clinical trial (Study ‘302’), position VDPHL01 to potentially become the first FDA-approved oral pill in nearly 30 years for pattern hair loss and a potential best-in-indication treatment option for the 50 million men with pattern hair loss in the US.
To date, six-month placebo-controlled data has been reported for more than 1,000 participants in registration-directed studies of VDPHL01 for the treatment of male pattern hair loss.
Study ‘304’ enrolled 536 participants who were randomised to receive either VDPHL01 8.5mg once daily (QD), VDPHL01 8.5mg twice daily (BID) or placebo. The trial met all primary and secondary endpoints with high statistical significance, demonstrating a potentially differentiated clinical profile defined by rapid onset of activity, consistent response across participants, and robust 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.
Reid Waldman, CEO of Veradermics, said: “With topline findings from our phase 3 Study ‘304’, we have now reported positive topline placebo-controlled data from two registration-directed trials that together enrolled more than 1,000 male participants. These results indicated that our proprietary, extended-release VDPHL01 formulation delivered marked increases in hair growth, while minimising side effects and cardiac risk.”
“Based on these results, we believe VDPHL01 has the potential to transform the treatment of pattern hair loss for millions of people. Later this year, we also anticipate reporting the longer-term data from Part B of Study ‘302’, further extending the safety findings of VDPHL01 in males through 12 months.”
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 extended-release formulation uses a gel matrix to deliver long-lasting, steady release of minoxidil for sustained absorption. This is 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 FDA-approved oral non-hormonal treatment for pattern hair loss in both male and female patients.