Santhera and ReveraGen have announced their first patient has been dosed in the FDA-funded Phase 2 Pilot study with Vamorolone in Becker muscular dystrophy (BMD).
This Phase 2 pilot study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and exploratory clinical efficacy of motor function outcomes of vamorolone compared to placebo over a treatment period of 24 weeks in 39 males (aged 18 and 64 years) with BMD.
“There are currently no approved drugs for BMD in any country, and no drugs in clinical development for this indication in the USA or Europe. Vamorolone has shown efficacy in the pivotal VISION-DMD study in Duchenne muscular dystrophy (DMD), a more severe but related disease, and, based on these findings and its mechanisms of action, this developmental compound may show a benefit in BMD.”
Eric Hoffman, PhD, President and CEO of ReveraGen BioPharma
The clinical trial currently plans to enroll at sites in Pittsburgh (USA) and Padova (Italy).
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