• MIN-117 study did not meet its primary (MADRS) and key secondary (HAM-A) endpoints
  • MIN-117 was generally well-tolerated with a safety profile comparable to placebo

WALTHAM, MA, USA I December 18, 2019 I 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.

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.”

About this study (www.clinicaltrials.gov Identifier NCT03446846)

This study was a 6-week, 3-arm, randomized, double-blind, placebo-controlled trial to investigate the safety and efficacy of MIN-117 in adult patients. 360 patients were randomly assigned to 1 of 3 treatment arms, including placebo, 5.0 mg. MIN-117 or 2.5 mg. MIN-117, in a 2:1:1 ratio. Patients enrolled in this study were diagnosed with moderate or severe MDD with anxious distress and without psychotic features. The study design had 3 phases: a screening phase of up to 3 weeks (including washout), a 6-week double-blind treatment phase, and a post-study follow-up visit. 40 sites in the U.S. and Europe participated in the trial.

The primary efficacy endpoint was the change in MADRS total score from baseline (the start of double-blind treatment) to the end of the double-blind treatment period (week 6). The primary comparisons were between each MIN-117 dose group and the placebo group. Secondary efficacy evaluations include the HAM-A, CGI-S, and CGI-I, as well as safety over six weeks of treatment.

About Minerva Neurosciences

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat CNS diseases. Minerva’s proprietary compounds include: roluperidone (MIN-101), in clinical development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and Major Depressive Disorder (MDD); and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visit http://www.minervaneurosciences.com.

SOURCE: Minerva Neurosciences