Veradermics shares climbed 2.3% on Monday after the biotech released 12-month data from a Phase 2/3 study of its oral extended-release minoxidil pill, VDPHL01, for male pattern hair loss.
- Extended-Release Delivery: The drug uses a gel matrix designed to slow down absorption in the body, preventing high peak blood concentrations and maintaining steady drug levels.
- Non-Vellus Hairs: Clinical trials specifically measure non-vellus hairs, which are thicker, pigmented terminal hairs rather than fine, barely visible peach fuzz.
- Androgenetic Alopecia: The medical term for common male and female pattern baldness driven by genetic and hormonal factors.
In Part B of Study 302, 519 men with mild-to-moderate androgenetic alopecia received either 8.5 milligrams of VDPHL01 once daily, twice daily, or a placebo for six months. After the six-month mark, patients originally given the placebo crossed over to active treatment for the remainder of the 12-month evaluation period.
Participants on the twice-daily dosing schedule recorded a gain of 43.9 non-vellus hairs per square centimeter from baseline at Month 12. Meanwhile, the once-daily group added 29.7 hairs per square centimeter over the same timeframe.
BioSpace reported that earlier data from Study 304 showed once-daily patients improved by 28.6 hairs per square centimeter and twice-daily patients by 36.4 hairs per square centimeter at six months, compared to 6.6 hairs for the placebo group.
| Measure at Month 12 | Twice Daily | Once Daily |
|---|---|---|
| Non-vellus hair gain (hairs/cm2) | 43.9 | 29.7 |
| Visible improvement (AAIRS) | 89.1% | 79.8% |
| Rated improved or much improved | 68.0% | 48.4% |
| Investigator Global Assessment improved | 92.2% | 74.4% |
| Crossover hair gain (hairs/cm2) | 32.1 | 24.5 |
| Crossover visible improvement | 82.0% | 73.2% |
Patient-reported outcomes tracked closely with quantitative hair density measurements. On the Androgenetic Alopecia Impact Rating Scale, 89.1% of twice-daily participants and 79.8% of once-daily participants reported visible coverage improvements.
BioSpace noted that on secondary measures evaluating investigator perception of hair growth, 82.7% of twice-daily patients and 78.8% of once-daily patients showed improvement, compared to 35.3% of the placebo cohort.
$MANE …. Veradermics reports 12-month Phase 2/3 VDPHL01 data, with twice-daily dosing increasing hair count by 43.9 hairs/cm² (138.78) Veradermics announces positive topline results from Part B of its Phase 2/3 Study '302' evaluating VDPHL01, an extended-release oral minoxidil… pic.twitter.com/917IavFUoM
Veradermics reported that VDPHL01 was generally well tolerated through 12 months. The study recorded no treatment-related serious adverse events, no cardiac-related adverse events of special interest, and no new safety signals.
The company debuted on public markets with a $256.3 million initial public offering and subsequently secured an additional $472 million, establishing itself as a prominent post-IPO biotech standout. CEO Reid Waldman told BioSpace that the booming consumer market for GLP-1 weight loss drugs helped prove patients are willing to take healthcare solutions into their own hands.
Hair loss could be the next weight loss,
Reid Waldman told BioSpace.
If cleared by the U.S. Food and Drug Administration, VDPHL01 would represent the first oral pill approved for pattern hair loss in nearly three decades, targeting an estimated U.S. market of 50 million men and 30 million women. Veradermics plans to report data from its Phase 2/3 trial evaluating female pattern hair loss in the first half of 2027.
