Veradermics’ hair loss data package looks to be FDA-ready.
Topline results are in for part B of the New Haven biotech’s phase 2/3 clinical trial in men with mild-to-moderate pattern hair loss, and the drug candidate, VDPHL01, did not disappoint. VDPHL01 achieved continued hair growth through one year and reported its highest hair count in the phase 3 program so far.
VDPHL01 is an oral extended-release formulation of minoxidil—best known for being the active ingredient in Rogaine. Minoxidil was originally approved in the 1970s as a treatment for high blood pressure. Today, the generic is commonly prescribed off label as a hair-loss treatment, but the instant-release formulation can come with unwanted cardiac side effects and less-than-optimum impacts on hair growth. Veradermics attests that its extended-release design provides a steady absorption for better hair growth while avoiding the high concentrations that impact blood pressure.
In the trial, dubbed Study 302, 519 men were randomized to receive VDPHL01 8.5 mg once daily, twice daily or placebo for six months. Part A of the study met is co-primary endpoints, with VDPHL01 both increasing non-vellus target area hair count and patient-reported hair coverage over placebo.
After six months, the trial transitioned to part B, designed to test 12-month safety and ongoing efficacy of VDPHL01. At this time, the trial’s placebo group was crossed over into one of the two treatment arms for the final six months.
Citi analysts called the trial's part B data “better than expected,” especially in patients who were on the twice-daily dose for a full year. For these patients, non-vellus hair count at 12 months was up 43.9 hairs/cm², the highest hair count reported in any of Veradermics’ phase 3 trials so far and up from 33 hairs/cm² at six months. Veradermics called the outcome a “deepening of hair growth”.
For patients who were on the once-daily dose for the full 12 months, VDPHL01’s hair growth effects held steady, with non-vellus hair count up by 30.0 hairs/cm² at six months and 29.7 hairs/ cm² at one year.
Before VDPHL01, only topical minoxidil 5% and finasteride 1 mg has been studied in 12-month phase 3 trials for hair loss, delivering hair count boosts of 18.6 hairs/cm² and 16.9 hairs/cm², respectively, according to data shared by Veradermics CEO Reid Waldman, M.D., on an investor call Monday morning. While cross trial comparisons are unreliable, the difference in hair count improvement offers an idea of the gap VDPHL01 stands to fill.
From the patient perspective, 89.1% of patients in the twice-daily arm and 79.8% in the once daily arm reported visible hair coverage improvement on the Androgenetic Alopecia Impact Rating Scale (AAIRS) at the end of 12 months. And 68% in the twice daily arm and 48.4% in the once daily arm self-reported their hair coverage as improved or much improved on the AAIRS.
As for the placebo patients that switched over to twice daily VDPHL01, their non-vellus hair count increased 32.1 hairs/cm². And those that switched to the once daily saw a 24.5 hairs/cm² increase. Eighty-two percent of twice daily-dosed patients reported visible improvements according to AAIRS, as did 73.2% of patients on the once daily dose. And a significant number scored their hair coverage as improved or much improved, including 60% in the twice-daily group and 42.9% in the once daily arm.
Study 302 also measured investigator perception of hair growth improvements which were in line with patient reported outcomes. Investigators reported 92.2% and 74.4% of patients as having improved hair coverage in the twice-daily and once-daily arms, respectively. And in the placebo crossofver arms, investigators reported 83.9% and 80% of patients on the twice-daily and once-daily doses, respectively, as having improved hair coverage.
“The consistency of response observed at both the Month 6 and Month 12 timepoints, together with high rates of improvement reported by both participants and investigators, may increase the potential for long-term patient adherence to VDPHL01, if approved,” Veradermics said in a statement.
VDPHL01 continues to shine on the safety front with consistent findings compared with previous findings. There were no treatment-related serious adverse events, no adverse events of cardiac origin, and no treatment-emergent adverse events that cause discontinuation. Safety in the placebo crossover group was comparable to the two continuation groups.
The part B topline win follows Study 302’s part A readout in April which met all of its primary endpoints. And in October, Study 304, a separate phase 3 trial of 536 men with pattern hair loss cleared all its primary and secondary endpoints. With male data now in hand, Veradermics now awaits topline results from its phase 2/3 Study 306 in female pattern hair loss to read out in the first half of 2027.
As for its regulatory strategy, Veradermics is keeping things vague. In an investor call on the data, the biotech opted not to share whether it would pursue a male-only FDA approval, given the regulatory-ready data package, or if it would wait on the female trial to file an application with the FDA. The company also bypassed questions on whether it would seek approval for both the once-daily and twice-daily dosing regimens.
If approved, VDPHL01will be the first oral hair loss treatment to make it through the FDA in 30 years. According to Veradermics. the condition is the single most common chronic dermatological condition in the U.S. impacting roughly 80 million men and women, representing a market worth upwards of $30 billion by 2028.