Minerva Neurosciences Inc. (NASDAQ:NERV) has announced that its third phase study of roluperidone in the treatment of negative schizophrenia symptoms failed to meet primary and main secondary endpoints. The primary endpoint was the reduction in PANNS Marder Negative Symptoms Factor Score, while the secondary endpoint was the improvement in the Personal and Social Performance Scale Total score.
Phase 3 roluperidone enrolled 515 participants
The study enrolled around 515 participants in which the 513 patients who received treatment were incorporated in the Intent-To-Treat and safety population. The company conducted the trials in the US, Israel, and Europe. Out of the total enrolled patients, 172 received 32mg of roluperidone, 172 received a placebo while 171 patients received 64mg of roluperidone.
The data from roluperidone doses versus placebo in both the primary and secondary endpoints to the twelfth week were corrected for multiplicity through the truncated Hochberg measure. The main objective of the study was to assess change from baseline to the twelfth week of NSFS with both 32mg and 64mg roluperidone doses. This was in comparison to Schizophrenia patients showing moderate to severe negative symptoms. Unfortunately, neither the 32 mg dose nor the 64mg dose of roluperidone demonstrated statistically noteworthy difference from placebo.
64mg roluperidone doe showed encouraging results
Philip Harvey, the director of psychology division at the University Of Miami Miller School Of Medicine, indicated that there were some improvements in the PSP scale for the 64mg dose, which is encouraging. Harvey added that the study represented an important result in the study of possible treatment of negative symptoms in schizophrenia patients. He added that this was one of the most vital drivers of disability in these patient groups.
Minerva CEO Remy Luthringer indicated that they were delighted by the trial’s results expanding on the Phase 2b study that demonstrated improvement in primary and various secondary endpoints. He added that despite results from the study not meeting endpoints because of a larger than anticipated placebo effect at the twelfth week, the data from the 64mg dosing of roluperidone nonetheless showed promise in the treatment of negative symptoms.