Minerva Schizophrenia-Drug Trial Misses Key Endpoints

Roluperidone, a Minerva Neurosciences schizophrenia-drug candidate, failed to meet its key endpoints. But the company is undaunted.
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Shares of Minerva Neurosciences  (NERV) - Get Report dropped on Friday after the biopharma said that a schizophrenia drug candidate missed its key endpoints in a Phase III trial. 

The Phase III trial of roluperidone "to treat negative symptoms in schizophrenia did not meet its primary … or key secondary … endpoints,” the company said in a statement.

At last check shares of the Waltham, Mass., company traded at $2.52, down 81%. The stock had risen 85% in the three months through Thursday.

The primary goal was a reduction in Panss Marder Negative Symptoms. And the secondary goal was improvement in the Personal and Social Performance Scale.

“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 symptom,” the company said.

“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.”

But all isn’t lost, Minerva said.

"Even though this study didn't achieve its primary and key secondary endpoints, primarily due to a larger-than-expected placebo effect at Week 12, results obtained with the 64 mg 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," Chief Executive Remy Luthringer said in a statement.