Minerva Neurosciences Shares Jump On Positive Results From Phase IIB Study of MIN-101 Monotherapy

Minerva Neurosciences, Inc. NERV, a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, remained attractive on Thursday. The reaction followed after the company revealed positive top line results from a prospective Phase IIb, 12-week, randomized, double-blind, placebo-controlled parallel clinical study evaluating the efficacy, safety and tolerability of MIN-101 in patients with negative symptoms of schizophrenia. Mnerva Neurosciences said that these negative symptoms, for which no approved treatment is available currently, affect the majority of schizophrenic patients and could persist over their lifetimes. The company pointed out that the trial achieved its primary endpoint successfully, demonstrating the statistically significant gain 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 biopharma firm said that 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. Minerva's president and CEO, Remy Luthringer, commented, "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. Negative symptoms contribute substantially to poor quality of life and functional outcomes of schizophrenic patients." Luthringer also said, "We also observed consistent improvements in multiple secondary endpoints. This broad impact underscores the potential of MIN-101, a molecule that combines sigma2 antagonism and 5-HT2a antagonism, as a promising differentiated treatment for a debilitating disease affecting large numbers of underserved patients worldwide. Because negative symptoms are not only present in schizophrenia but also in brain degenerative disorders and other mental illnesses, we believe that MIN-101 may be a candidate for the potential treatment of other indications." Following the news, the stock jumped 190 percent on Thursday.