Minerva Neurosciences announced that its phase 3 trial of roluperidone (MIN-101) did not meet the primary and key secondary end points for the treatment of negative symptoms in schizophrenia.
The 12-week, multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of roluperidone in 515 adult patients with moderate to severe negative symptoms of schizophrenia. Patients were randomized to receive roluperidone 32mg, 64mg, or placebo. The primary end point was the change from baseline to week 12 in negative symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptoms Factor Score (NSFS). A key secondary end point was the improvement in the Personal and Social Performance scale total score (PSP).
Results showed that roluperidone 32mg (P ≤.256; effect size [ES]=0.1) and 64mg (P ≤.064, ES=0.2) were not found to be statistically significantly different from placebo for the primary end point. Moreover, neither dose was associated with statistically significant improvements in PSP at week 12 (32mg: P ≤.542, ES=0.1; 64mg: nominal P ≤.021, ES=0.3).
An unadjusted statistically significant separation from placebo was observed with both doses in NSFS at week 4 (32mg: nominal P ≤.036, ES=0.2; 64mg: nominal P ≤.007, ES=0.3), and at week 8 for the 64mg dose (nominal P ≤.027, ES=0.3). Additionally, roluperidone 64mg was found to be statistically significantly different from placebo as measured by PSP total score change at week 4 (nominal P ≤.005; ES=0.3) and week 8 (nominal P ≤.018; ES=0.3).
“We are encouraged by the results obtained in this study which expand upon the outcome of the phase 2b study that showed improvements in the primary end point and in multiple secondary end points,” said Dr Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “Even though this study didn’t achieve its primary and key secondary end points, primarily due to a larger than expected placebo effect at week 12, results obtained with the 64mg dose including the early onset of effect and functional improvement as measured by PSP suggest roluperidone merits continued investigation for the treatment of primary negative symptoms.”
The Company plans to consult with the Food and Drug Administration regarding next steps for roluperidone development.
For more information visit minervaneurosciences.com.