Minerva : MIN-101 Meets Primary & Secondary Endpoints In Phase IIB Trial

(RTTNews) - Minerva Neurosciences, Inc. (NERV) announced positive top line results from a prospective Phase IIb, 12-week, randomized, double-blind, placebo-controlled parallel clinical trial evaluating the efficacy, safety and tolerability of MIN-101 in patients with negative symptoms of schizophrenia.These negative symptoms, for which no approved treatment is currently available, affect the majority of schizophrenic patients and can persist over their lifetimes.

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"We believe the results from this trial constitute a key step forward in the development of a novel treatment for schizophrenia and specifically the negative symptoms of the disease, which represent a significant unmet medical need," said Dr. Remy Luthringer, president and chief executive officer of Minerva.

The study successfully achieved its primary endpoint, demonstrating the statistically significant benefit of MIN-101 over placebo in improving negative symptoms as measured by the pentagonal structure model (PSM) of the Positive and Negative Syndrome Scale (PANSS). The effect was shown for both doses tested: 32 mg: p = 0.022 with an effect size of 0.45, and 64 mg: p = 0.003 with effect size of 0.58.

The study also demonstrated statistically significant benefit of MIN-101 over placebo on the PANSS three factors negative symptoms subscale for both doses tested: 32 mg: p = 0.006, with an effect size of 0.55, and 64 mg: p = 0.001 with an effect size of 0.70.

The consistency and robustness of the effect was also supported by the demonstrated statistically significant benefit of MIN-101 over placebo in multiple secondary endpoints.