Veradermics is keeping pace in an already high-octane year.
After a stellar IPO and more than 500% increase in its share price since February, the hair loss biotech now boasts more phase 3 data to support its lead candidate, VDPHL01.
VDPHL01 is an oral extended-release formulation of minoxidil—the same active ingredient used in topical hair loss mainstay Rogaine. And the latest topline results show Veradermics' candidate cleared all primary and secondary endpoints in a study of more than 500 men with mild to moderate pattern hair loss. The data, Veradermics said in an Oct. 19 release, also reflect "high statistical significance."
In the late-stage ‘304’ study, VDPHL01 bested placebo in a metric called target area hair count (TAHC). Participants who took VDPHL01 once daily for 6 months saw an average TAHC increase of 28.6 hairs/cm². And those who took the oral treatment twice daily experienced a 36.4 hairs/cm² TAHC bump, compared to a 6.6 hairs/cm² improvement in the placebo group.
From the patient perspective, 78.8% of those on the daily dose and 85% of patients on the twice-daily dose reported hair coverage improvement on the self-reported Androgenetic Alopecia Impact Rating Scale (AAIRS), versus 35.3% in the placebo arm. And 55.7% and 68.7% on the once- and twice-daily oral minoxidil dose, respectively, rated their hair coverage as “improved” or “much improved,” as compared to 15% on placebo.
On a conference call Monday morning, Veradermics CEO Reid Waldman, M.D., said the VDPHL01 cohort also tracked statistically significant benefits over placebo as early as two months into treatment.
The positive readout follows a separate phase 2/3 win in male pattern hair loss—study ‘302’ announced in April—and a phase 2 win in female pattern hair loss that read out in July. Together, the 302 and 304 data packages, including additional 302 topline results expected before year’s end, will lay the foundation for a future regulatory submission.
Oral minoxidil was originally approved by the FDA in 1979 as a treatment for low blood pressure. The generic is frequently prescribed off-label for hair-loss treatment. But the current instant-release forms limit hair regrowth potential and carry risks of cardiac toxicity—both of which Veradermics says its extended-release option is designed to address.
Jeffries analysts said the fact that Veradermics already has around 700 men taking its treatment across two phase 3 trials with no cardiac adverse events gives the company “a strong hand in NDA review.”
“We believe VDPHL01 has the potential to transform the treatment of pattern hair loss for millions of people,” Waldman said in a statement Monday. And with 302 and 304 data now in hand, Waldman said on the conference call that Veradermics believes “the totality of phase 3 data in males now supports VDPHL01, if approved, to be the highest confidence therapeutic option” for hair loss treatment.
According to Veradermics' estimates, hair loss is the most common chronic dermatologic condition, affecting 50 million men and 30 million women and constituting a market projected to be worth north of $30 billion by 2028. For the men, there hasn’t been a new FDA approved treatment on the market in 30 years. And for the women, no such specifically-indicated hair loss treatment has ever been approved.
In a previous interview with Fierce, Waldman said he believes hair loss treatments like VDPHL01 have the potential to follow in the footsteps of weight loss drugs as a cash-pay, consumer-directed market.
“You don’t have to teach anyone that they have hair loss. People intuitively know that. You need to teach them that there’s a worthwhile option that has a probability of achieving the outcomes they are looking for," he said on a recent episode of The Top Line.