“We believe these findings suggest an expanded therapeutic window and a significantly improved safety margin for roluperidone,” said Dr. Jay Saoud, Senior Vice President, Head of Research and Development at Minerva. "They provide further evidence that the formulation being used in the ongoing Phase 3 trial of roluperidone has a significantly reduced maximum concentration (Cmax) of the metabolite known as BFB-520 when compared to the formulation used in the Phase 2b trial, thereby reducing the potential of transient QTc increases at the doses currently tested in that Phase 3 trial.
“Furthermore, we believe these data suggest the potential for future testing of roluperidone in schizophrenic patients with an exacerbation of psychosis at higher doses than those being used in the Phase 3 trial,” said Dr. Saoud.