Veradermics’ share price has jumped more than 47% after its oral, extended-release version of minoxidil posted a win during a pivotal trial in male pattern baldness.
In Part A of the US-based Phase II/III study (NCT06724614), 519 patients with pattern hair loss were randomised to three arms to receive either a placebo or an 8.5mg dose of Veradermics’ drug, VDPHL01, once or twice daily. Minoxidil is a common off-label hair loss therapy.
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The trial’s primary endpoints focused on patient-reported treatment benefits and the change from baseline in non-vellus target area hair counts (TAHC), an objective measure of thick hair growth on the scalp, after six months of dosing.
During the study, VDPHL01 trumped placebo by triggering significant improvements in hair growth over placebo at the six-month mark, with patients receiving the once- and twice-daily doses achieving a non-vellus TAHC of 30.3 hairs/cm² and 33 hairs/cm² from baseline versus the 7.3 hairs/cm² placebo change.
Veradermics’ therapy also met the trial’s other co-primary endpoint, with 79.3% and 86% of patients in the once- and twice-daily dosing arm reporting better hair coverage on the androgenetic alopecia impact rating scale (AAIRS) compared with the 35.6% that achieved this goal in the placebo group.
Alongside its promising efficacy profile, the treatment population generally tolerated VDPHL01 well at the six-month mark, with similar rates of adverse event (AE)-associated discontinuation between the drug and placebo groups. No patients experienced serious cardiac AEs in this study – a known side effect associated with higher doses of oral minoxidil.
Following the positive outcome of this study, Veradermics’ stock value climbed 47% from $67.84 at market close on 24 April to $100.10 at the same time on 27 April.
VDPHL01’s hair loss market potential
VDPHL01’s success in this Phase II/III study will be welcome news for Veradermics, which is currently running a pivotal programme on the drug across both male and female pattern hair loss.
According to Dr Maryanne Makredes Senna, assistant professor of dermatology at Harvard Medical School, VDPHL01 could be a significant disruptor in the pattern hair loss indication. “An oral therapy that has improved hair loss in the eyes of nearly 80% of patients and investigators… and sits in a class that dermatologists are already comfortable prescribing, has the potential to transform the treatment landscape for male pattern hair loss,” she said in a statement.
If approved, VDPHL01 could become the first non-hormonal pill for pattern hair loss to get the US Food and Drug Administration (FDA) greenlight, which could reach a patient population of approximately 80 million in the US alone. It would also be the first hair loss drug to secure an approval in nearly three decades – highlighting the prior innovation drought in this indication.
In a research note from 22 April, Jefferies analysts noted that VDPHL01 could represent a $2bn+ market opportunity if the drug were to exceed the efficacy bars of a 15–20 hairs/cm² change in non-vellus TAHC growth and a 15-25% change in patient-reported outcomes versus placebo – both of which VDPHL01 achieved.
