Minerva Neurosciences has reported that roluperidone failed to meet endpoints in a Phase III clinical trial for the treatment of negative symptoms in schizophrenia.
The drug did not reach the primary endpoint of a decrease in PANSS Marder Negative Symptoms Factor Score (NSFS) and the main secondary endpoint of improvement in the Personal and Social Performance Scale Total Score (PSP).
A total of 515 participants were recruited in the Phase III trial conducted in the US, Europe and Israel, including 513 patients who were in the safety and Intent-To-Treat population and received treatment.
Of the total participants, 172 received placebo, 172 received roluperidone 32mg, and 171 received roluperidone 64mg.
The primary objective was the change of NSFS from baseline to week 12 with both doses of the drug compared to placebo in schizophrenia patients with moderate to severe negative symptoms.
According to the results, the 32mg and 64mg doses failed to demonstrate a statistically significant difference on NSFS and PSP compared to placebo.
Roluperidone was reported to be generally well tolerated. Incidences of patients with treatment‑emergent adverse events over the 12 weeks of treatment were 37% in the 64mg group, 42% in the 32mg arm, and 33% for patients on placebo.
Minerva Neurosciences executive chairman and CEO Dr Remy Luthringer said: “We are encouraged by the results obtained in this study which expand upon the outcome of the Phase IIb study that showed improvements in the primary endpoint and in multiple secondary endpoints.
“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 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 intends to discuss with the US Food and Drug Administration (FDA) the next steps in roluperidone’s development for this indication.