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Minerva Neurosciences Reports Topline Results From Phase 2b Trial of MIN-117 in Major Depressive Disorder
MIN-117 study did not meet its primary (MADRS) and key secondary (HAM-A) endpointsMIN-117 was generally well-tolerated with a safety profile comparable to
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"MIN-117 study did not meet its primary (MADRS) and key secondary (HAM-A) endpointsMIN-117 was generally well-tolerated with a safety profile comparable to placeboCompany to host conference call at 5:00 p.m. today (dial-in information below) WALTHAM, Mass., Dec. 18, 2019 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, announced today the Phase 2b trial of MIN-117 in adult patients suffering from moderate to severe major depressive disorder (MDD) and presenting with symptoms of anxious distress failed to meet its primary and key secondary endpoints.\n Neither dose of MIN-117 tested in this trial showed a statistically significant separation from placebo on the reduction in the symptoms of MDD over the 6-week treatment period as measured by the change in the Montgomery–Åsberg Depression Rating Scale (MADRS). In addition, neither dose showed a statistically significant separation from placebo on the key secondary endpoint, reduction of symptoms of anxiety as measured by Hamilton Anxiety Rating Scale (HAM-A) over the 6-week treatment period. Patients treated with the 2.5 mg dose experienced an improvement of 1.6 points compared to placebo at Week 2 (p≤ 0.029). No other statistically significant separation from placebo on HAM-A was observed. MIN-117 was generally well-tolerated, and the incidence of patients who reported treatment emergent adverse events over the duration of 6 weeks of treatment and 2 weeks of follow-up were 37% for the 2.5 mg, 39% for the 5 mg, and 38% for placebo. Only headaches were reported at ≥5% in this study at 12% for both the 2.5 and 5 mg, and 7% for placebo. There were no deaths, and only 5 patients in total discontinued from the study due to TEAE (2 for 2.5 mg, 1 for 5 mg, and 2 for placebo). “We are obviously disappointed with the results despite the trial having been very well executed,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “We express our sincere appreciation to all of the patients, the investigators and their staff who participated in this trial. At present, we have no plans for further clinical development of the molecule in MDD.” Conference call Minerva will hold a conference call and live audio webcast on De...