In the wake of a successful IPO and strong stock growth throughout the year, Veradermics now has late-stage data to support a regulatory package for its hair loss pill.
Coming off a February IPO that brought in more than $256 million, hair loss biotech Veradermics’ lead asset has shown improved hair coverage in men during a Phase 3 trial.
VDPHL01, which is an oral extended-release formulation of minoxidil, which showed significant improvement in patient-reported outcomes over placebo.
The clinical results cap off a meteoric year for the biotech since the IPO, which was followed by a massive stock surge in the ensuing months. The Connecticut-based drugmaker had been building up to the release of late-stage data for the drug candidate, called VDPHL01, which sets the company up for potential FDA approval.
The trial, named Study 304, included more than 500 males with mild-to-moderate pattern hair loss who received either VDPHL01 once or twice a day, or placebo. For one of the two co-primary endpoints measuring hair thickness, patients in the once-daily group had an improvement of 28.6 hairs per square centimeter, while the twice-daily cohort saw an improvement of 36.4 hairs per square centimeter, compared with 6.6 hairs per square centimeter for placebo comparators after six months.
On the second endpoint that measured patient-reported outcomes, 55.7% of men in the once-daily cohort showed “improved” or “much improved” hair coverage based on a rating of alopecia severity, while 68.7% in the subset that received twice-daily medication reported the same. Of patients in the placebo group, 15% reported improvement.
A secondary measure of investigator perception of hair growth was also statistically significant, with 78.8% of once-daily patients and 82.7% of twice-daily patients showing improvement, compared to 35.3% of patients in the placebo group.
Veradermics designed its version of minoxidil, also the main ingredient in the household hair loss brand Rogaine, to be delivered in an extended-release formulation using a gel matrix for sustained absorption to improve efficacy and safety, according to the company. The delivery method helps avoid high peak concentrations, allowing more time for hair growth, the company said in a release.
For the approximately 50 million men and 30 million women with pattern hair loss, also called androgenetic alopecia, no FDA-approved treatment has entered the U.S. market in almost 30 years, according to Veradermics.
The company has not announced a timeline for a regulatory submission but said the data would be used to support an application. The company plans to hold a conference call Monday morning to discuss the results.
Veradermics CEO Reid Waldman toldBioSpace in July that the thriving consumer market behind GLP-1 weight loss drugs from industry giants Eli Lilly and Novo helped convince him and his team that “hair loss could be the next weight loss,” demonstrating that patients would be willing to take certain parts of healthcare into their own hands.
In addition to Study 304, Veradermics is running an ongoing Phase 2/3 trial called Study 302 featuring men with pattern hair loss. This study has already shown similar efficacy results and will contribute to the future regulatory submission. Updated results from a second part of Study 302 will be revealed later this year, according to the company.
The small drugmaker has also finished enrollment in a Phase 2/3 study for female pattern hair loss and expects to read out results in the first half of next year.
Veradermics is not the only biotech in the game. Pelage Pharmaceuticals is also racing to market with a novel therapy called PP405 that is currently in Phase 2/3 testing. A Phase 2a read out last year showed that 31% of male patients with a higher degree of hair loss had a greater than 20% increase in hair density at week eight.
