Santhera Pharmaceuticals has announced that partner ReveraGen Biopharma has completed a long-term, open-label extension study of 24 months duration with Vamorolone in patients with Duchenne muscular dystrophy. Including 6 months treatment in the preceding study, ReveraGen has now obtained safety and efficacy data with Vamorolone over a period of 2.5 years in 41 boys with Duchenne.
“With most participants continuing treatment with vamorolone long-term, we have assembled a solid safety database, with 106 patient-years of Vamorolone exposure in DMD boys, with no serious adverse events attributable to Vamorolone to date,” said Eric Hoffman, PhD, Vice President of Research at ReveraGen BioPharma. “We will now analyse the efficacy data and plan to report the results in upcoming scientific conferences and publications.”
The Duchenne Research Fund together with Duchenne UK and Joining Jack awarded $1m to ReveraGen to support the Phase 1 trial of Vamorolone – a steroid alternative.