Minerva says Phase 3 trial of roluperidone did not meet primary endpoint
Minerva Neurosciences (NERV) announced that the Phase 3 trial of roluperidone to treat negative symptoms in schizophrenia did not meet its primary and key secondary endpoints.
In total, 515 patients were enrolled into the trial, and 513 patients received treatment and were included in the safety and Intent-To-Treat population.
The trial was conducted in the USA, Europe and Israel.
There were 172 patients who received placebo, 172 patients who received roluperidone 32 mg, and 171 patients who received roluperidone 64 mg.
Demographic and baseline disease characteristics were comparable across all treatment arms.
The results for both roluperidone doses versus placebo across both the primary and the key secondary endpoints to Week 12 were corrected for multiplicity using the truncated Hochberg procedure.
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.
Furthermore, neither dose showed a statistically significant separation from placebo on the key secondary endpoint, the change from baseline to Week 12 in PSP.
Although limited inferences can be drawn from this data, unadjusted statistically significant separations from placebo were observed in NSFS at Week 4 for both doses and at Week 8 for the 64 mg dose, and the 64 mg dose was statistically significantly different from placebo as measured by change in PSP at all other assessment timepoints.
Overall, subgroup analyses by region and by age groups were similar.
Roluperidone was generally well tolerated, and the incidences of patients who reported treatment-emergent adverse events over the duration of 12 weeks of treatment were 37% for the 64 mg group, 42% for the 32 mg group, and 33% for placebo.
Only 42 patients discontinued from the study due to adverse events, 16 in 64 mg arm, 18 in 32 mg arm, and 8 in placebo arm.
Two treatment-unrelated deaths were reported in the 32 mg treatment arm says Phase 3 trial of roluperidone did not meet primary endpoint.
NERV is down 82% to $2.50.
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