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news.Samumed has completed a Phase II clinical trial for its potential treatment of androgenetic alopecia (AGA), commonly known as male pattern baldness.
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There were no serious adverse events (SAE) observed in either of the treatment groups, and the incidence of adverse events (AE) was similar between treatment and control groups. The company will report exploratory efficacy data, including change over time in non-vellus hair count and hair density, when they become available.
Samumed’s investigational drug is a topical solution of its novel small molecule compound SM04554.
The 300-subject, multi-center, randomized (1:1:1), double-blind, vehicle-controlled Phase II trial studied the safety, tolerability and efficacy of two different concentrations of SM04554 in male subjects with AGA between the ages of 18 and 55 with Norwood-Hamilton Classification scores of 4, 5, 5A, 5V, or 6. The study involved a 90-day once-a-day treatment period and a 45-day post-treatment follow up.
Samumed chief medical officer Yusuf Yazici said: "We are very encouraged by the safety profile of SM04554, with no SAEs observed in any treated patient in either study.
"We are hoping to see exploratory efficacy data consistent with our promising preclinical results, which would constitute another significant milestone for Samumed.
In preclinical in vivo studies, SM04554 has been shown to generate new hair follicles and increase hair count in multiple animal models.