Onabotulinumtoxin A

Veradermics has succeeded in its first major test as a newly-minted public company. The biotech’s form of oral Rogaine cleared the bar in a Phase 2/3 trial in men with mild-to-moderate pattern hair loss, producing statistically significant improvement in hair growth starting as early as month two. Both once- and twice-daily versions of the drug, called VDPHL01, led to “rapid and robust hair growth,” Veradermics said on Monday. At month six, once-daily dosing led to an increase of target area hair count of 30.3 hairs/cm², while the twice-daily patients experienced a 33.0 hairs/cm² increase. Placebo participants saw a 7.3 hairs/cm² improvement. The growth is measured by photographing the same square centimeter, as located by a red spot tattooed on the head, over the course of the study. The photos are assessed via a digital analysis algorithm from a vendor with more than three decades of experience in the field, CEO Reid Waldman told Endpoints News. The study’s patient-reported outcome (PRO) co-primary endpoint also came in at a high mark. About 79% and 86% of patients on the once- and twice-daily regimens, respectively, reported PRO improvements. About 36% of placebo participants could say the same. The PRO involved patients looking at themselves at baseline and then again at their six-month follow-up visit. They assessed their hair on a seven-point scale that goes from “much worse” to “much improved.” The trial included more than 500 participants. Waldman, a trained dermatologist, said the data beat internal expectations. Going into the readout, Veradermics’ success benchmark was “a profile that essentially would look like an oral Rogaine foam with good safety but the convenience of oral administration,” Waldman said. “And that is a profile that we have just smashed with this data,” he added. The company said Monday the drug’s safety and tolerability were “similar to placebo.” About 5% of patients experienced lower extremity edema, but only 1% discontinued the study for that reason, Waldman said. About 5% of patients experienced hypertrichosis, or excessive hair growth, but there were no discontinuations for that adverse event, he added. VDPHL01 is a non-hormonal medicine and is an oral version of minoxidil, long known as Rogaine. Oral versions have been taken off-label for hair loss before but heart issues have caused hiccups for broader use. Veradermics has been working for almost seven years on an extended-release version with a gel matrix that delivers the drug more slowly and gets rid of those cardiac concerns. There’s another Phase 3 trial in men to read out in the second half of this year. Veradermics will likely then submit the drug for FDA approval. Another Phase 3 in women could be submitted at the same time or at a later date, Waldman said. The company plans to apply the burgeoning direct-to-consumer pharma model to the hair growth industry. With the popularity of GLP-1 medicines for obesity and medical cosmetic products like Botox, the company has precedent to work off of in terms of mapping out its commercial future. The New Haven-based biotech believes pattern hair loss is the “largest aesthetics market worldwide,” with 80 million people in the US alone having pattern hair loss. Waldman said Veradermics is “laser-focused this year on building a credible and independent commercial organization.” The company already has a veteran chief commercial officer who is preparing for market launch. It said last month that it has enough money to get into 2029, including fuel for a potential commercial entry. The company bagged more than $250 million in its NYSE entry in early February. The market was happy. Its shares $MANE popped 122% in that first trading session.