Veradermics reported “positive top line results” from Part A of its Phase II/III 302 trial evaluating VDPHL01, an oral extended-release minoxidil tablet, in men with mild to moderate pattern hair loss. On a conference call, CEO Dr. Reid Waldman said the randomized, double-blind, placebo-controlled study achieved “a high degree of statistical significance in both co-primary endpoints and all key secondary endpoints in both dose groups,” while also showing a safety profile he characterized as “placebo-like overall AE rates.”
Trial design and endpoints
According to Waldman, Study 302 enrolled 519 male subjects across 44 U.S. sites. The company presented results from Part A, the six-month placebo-controlled period, for once-daily (QD) and twice-daily (BID) dosing versus placebo.
- Target Area Hair Count (TAHC), measuring non-vellus hairs (>30 microns) per square centimeter using standardized photography and digital image analysis with quality assurance review.
- A patient-reported outcome (PRO) responder analysis on the Androgenetic Alopecia Impact Rating Scale (AAIRS), measuring the percentage of patients rating themselves “improved” or “much improved” based on standardized photo comparisons.
Waldman highlighted baseline characteristics he said made the population representative, including enrollment up to age 65, with about 60% over age 40, and an ethnically diverse group. He also said the study did not “cherry-pick” for safety, noting that the majority of subjects had a cardiac risk factor—high blood pressure—which he said is relevant because hypertensive individuals can be more sensitive to minoxidil’s hemodynamic effects.
Efficacy: hair count gains and patient-reported improvement
On the TAHC endpoint, Waldman reported an increase of 30.3 non-vellus hairs in the QD arm and 33 in the BID arm at month six. He said the QD performance was “one of the big surprises” and described the results as “leading data on this endpoint,” while cautioning that comparisons to other therapies are cross-trial and not head-to-head.
Waldman said Veradermics’ data suggest a “150%-300% greater benefit” than oral minoxidil 5 mg, topical minoxidil 5% foam, and finasteride 1 mg, adding that the company’s results were reported on an intention-to-treat basis.
On AAIRS, Waldman said nearly half of patients in the QD arm and nearly two-thirds in the BID arm rated themselves as improved or much improved at month six. He added that at month six, nearly 90% of BID patients and nearly 80% of QD patients reported improvement in hair coverage. He also pointed to consistency with the Investigator Global Assessment (IGA), arguing that alignment between physician assessment and patient perception could support real-world adoption.
Safety: placebo-like adverse event rates and no cardiac AESIs
Waldman said the company observed no drug-related serious adverse events and no adverse events of special interest (AESIs) of cardiac origin, specifying no pericardial effusion, pleural effusion, angina, or heart failure. He also stated there were no clinically meaningful changes in heart rate, blood pressure, or ECGs.
He added that overall adverse event rates and adverse event-related discontinuation rates were “placebo-like,” and that adverse events were primarily mild to moderate and often self-resolving.
The only events occurring in more than 5% of patients with an imbalance between active and placebo were edema and hypertrichosis. Waldman said edema led to a discontinuation rate “approaching 1%,” while hypertrichosis resulted in “zero discontinuations.” He also said participants did not report increased hair shedding after treatment initiation—an effect he described as common with topical and immediate-release oral minoxidil.
Clinical perspective: unmet need and early adoption potential
Scientific Advisory Board member Dr. Maryanne Makredes Senna, a board-certified dermatologist and Harvard Medical School assistant professor, described hair loss as deeply impactful and said patients often dislike topical treatments. She said finasteride can fall short on satisfaction in her practice and that patients are concerned about hormonal and sexual side effects. Senna also discussed her experience prescribing immediate-release oral minoxidil off-label, saying patients may see initial improvement but then plateau, with side effects emerging when doses are increased.
Regarding VDPHL01, Senna said the trial design was “robust and… rigorous” and that the hair count “far surpasses what we’re seeing with other therapies.” She called the safety signal “very reassuring,” particularly given that many study participants had cardiovascular risk factors. Senna emphasized the PROs, saying that seeing 86% of patients report improvement is “enormous,” and added that results as early as two months address major prescriber priorities of efficacy, safety, and patient satisfaction. She said that, if approved, the therapy would be “a no-brainer as a first-line therapy” and could “very quickly… catch on as the first-line treatment.”
Commercial read-through: market survey and pricing benchmark
Chief Commercial and Strategy Officer Mark Neumann described pattern hair loss as “the largest aesthetics market in the world” and said the company conducted a market survey “this weekend” following receipt of the top-line results. He said the double-blinded quantitative and qualitative research included 153 healthcare providers and 190 male patients, with respondents spanning both currently treated and untreated segments.
Neumann said more than 90% of both HCPs and patients viewed VDPHL01 as positively differentiated versus available options, with about two-thirds rating it as very or extremely positively differentiated. He also reported that 73% of HCPs were very or extremely likely to prescribe VDPHL01 once approved, and that over 70% of patients were highly likely to talk to their doctor about it.
In Q&A, Waldman said it was “too early” to decide between QD and BID regimens for filing, citing another ongoing Phase III trial and longer-term follow-up from Study 302 expected later in the year. He also said the data could “change the conversation” from stabilization as success toward expecting measurable regrowth.
Asked about longer-term outcomes beyond six months, Waldman said the company does not yet have data to guide expectations but noted hair length still takes time to grow even if density improves.
Regarding pricing, Neumann said final decisions would be made closer to launch. He cited Nutrafol as an “in-market benchmark” at about $90 per month, saying it has “close to 2 million patients” and generates “over $1 billion a year.” He said Veradermics plans additional pricing sensitivity and willingness-to-pay research with physicians and patients.
Veradermics also said a second male readout is anticipated in the second half of the year, alongside ongoing work in a female trial, with Waldman stating that 2026 could be “a transformational year” including top-line results from the final registration-directed male study and 12-month data from Study 302.
About MANE (NYSE:MANE)
MANE is a global manufacturer and supplier of flavors, fragrances and ingredients for the food, beverage, personal care, household and fine fragrance markets. Headquartered in France, the company develops and produces aromatic solutions that are used by consumer goods companies, food processors, perfumers and formulators seeking sensory impact, taste modulation and olfactory character for their products.
The company’s product portfolio includes savory and sweet flavor systems, beverage concentrates, natural extracts, essential oils, fragrance compounds, cosmetic ingredients and specialty functional solutions such as taste enhancers and odor masking agents.
