-=Minerva Neurosciences (NERV) : schizophrenia drug trial misses key endpoints

Minerva Neurosciences announces that the Phase 3 trial of roluperidone to treat negative symptoms in schizophrenia did not meet its primary and key secondary endpoints 

The primary objective of the trial was to evaluate the change from baseline to Week 12 of NSFS with 32 mg and 64 mg doses of roluperidone compared to placebo in patients diagnosed with schizophrenia presenting with moderate to severe negative symptoms. Neither the 32 mg nor 64 mg dose of roluperidone showed a statistically significant separation from placebo (32 mg: p =0.256, effect size [ES]=0.1; 64 mg: p =0.064, ES=0.2). Furthermore, neither dose showed a statistically significant separation from placebo on the key secondary endpoint, the change from baseline to Week 12 in PSP (32 mg: p =0.542, ES=0.1; 64 mg: nominal p =0.021, ES=0.3).