Minerva Neurosciences (NERV) Announces FDA Accepted IND Application for MIN-117 and Offers Update on MIN-101
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Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced recent progress in its clinical programs with MIN-101 for schizophrenia and with MIN-117 for major depressive disorder (MDD).
The last patient has completed the 24-week open-label extension period of the Company’s Phase IIb clinical trial of MIN-101 in patients with negative symptoms of schizophrenia. Positive results from the prospective 12-week randomized, double-blind, placebo-controlled core phase of this trial were announced previously. These results from the core phase demonstrated statistically significant improvement of negative symptoms, the primary endpoint of the trial, in patients treated with both 32 milligrams (mg) and 64 mg daily doses of MIN-101 compared to placebo. Statistically significant benefit of MIN-101 was also demonstrated in multiple secondary endpoints.
Approximately 140 patients who completed the core phase of this trial entered the extension phase, during which all patients received one of the two doses of MIN-101. Patients who received placebo in the core study were randomized to one of these doses. As planned, the extension phase of the trial was completed in the third quarter of 2016, and the Company expects to announce top line results from this phase in the fourth quarter of 2016. The Company has submitted results from the core phase of the trial for peer-reviewed publication and presentations and plans to meet with regulatory authorities in the United States and Europe in preparation for Phase 3 testing of MIN-101, which is expected to begin in 2017.
MIN-101 is a drug candidate with equipotent affinities for sigma 2 and 5‑hydroxytryptamine-2A (5-HT2A) and lower affinity at α1-adrenergic receptors. MIN-101 has no direct dopaminergic post-synaptic blocking effects, known to be involved in some side effects like extrapyramidal symptoms, sedation, prolactin increases and weight gain.
The U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application to begin clinical testing of MIN-117 in the United States. This acceptance follows positive results from a randomized, double-blind, placebo- and positive-controlled Phase IIa clinical trial in MDD with MIN-117 in Europe announced earlier this year. Data from the study demonstrated the dose-dependent superiority of MIN-117 over placebo in reducing symptoms of depression and anxiety.
FDA acceptance of the IND for MIN-117 allows the Company to begin clinical trials with this compound in the U.S., building upon the results from the European trial. Planning is underway for these trials, which are expected to begin in 2017.
MIN-117 is an antidepressant drug candidate with a differentiated mechanism of action targeting adrenergic alpha 1a, alpha 1b, 5-HT1A, 5-HT2A receptors, serotonin and the dopamine transporters.
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