Journal of Clinical Psychiatry Publishes Positive Results of Cognitive Performance From Phase 2B Trial of Roluperidone, Under Development by Minerva Neurosciences for the Treatment of Negative Symptoms in Schizophrenia
The manuscript, entitled “Cognitive Effects of MIN-101 in Patients with Schizophrenia and Negative Symptoms: Results from a Randomized Controlled Trial,” can be found online at https://doi.org/10.4088/JCP.17m11753.
Roluperidone is a novel compound with affinities for 5HT2A and sigma2 receptors and no direct binding to dopamine receptors. In this regard, roluperidone differs from drugs currently indicated for schizophrenia, all of which directly interfere with dopamine neurotransmission.
Results presented in this publication suggest a benefit of roluperidone on cognitive performance in schizophrenia patients with stable positive symptoms and moderate to severe negative symptoms. Researchers hypothesized that because roluperidone lacks the detrimental effects associated with currently available medications that do not benefit cognitive performance in patients with schizophrenia, the potential beneficial effects on cognition induced by 5HT2A antagonism and sigma2 antagonism would not be disrupted or diminished by other aspects of the compound’s mechanism of action.
“Currently available dopamine-blocking antipsychotic drugs have very little impact on cognitive impairment associated with schizophrenia,” said Dr.
Cognitive impairment is one of the primary drivers of functional disability in schizophrenia and an unmet medical need. Cognitive impairment in patients with this disease has been consistently associated with various aspects of diminished functioning, including unemployment, limited social interaction and poor quality of life.
Cognitive abilities in this study were measured by the Brief Assessment of Cognition in Schizophrenia (BACS) scale at baseline and after 4 and 12 weeks of treatment. In the analysis of the changes from baseline to the study endpoint (Week 12), scores on a motor test and on a test of verbal fluency were statistically significantly better than placebo. BACS composite z scores (z score distribution p = .05) showed statistically significant improvement in the roluperidone 32 milligram (mg) group compared to the placebo group. The T score for the BACS composite was close to significance (p = .06). There were no significant intergroup differences in the changes in the other BACS domains.
Additional analyses illustrate the correlations between the change in the BACS scores and the change in the Positive and Negative Syndrome Scale (PANSS) negative factor score.
Previously announced results from this trial, published in the
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and scope of current clinical trials and results of clinical trials with roluperidone; the timing and scope of future clinical trials and results of clinical trials with roluperidone; the clinical and therapeutic potential of roluperidone; our ability to successfully develop and commercialize roluperidone; the sufficiency of our current cash position to fund our operations; and management’s ability to successfully achieve its goals. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether roluperidone will advance further in the clinical trials process and whether and when, if at all, it will receive final approval from the
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Source: Minerva Neurosciences, Inc