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) endpoints
- MIN-117 was generally well-tolerated with a safety profile comparable to placebo
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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.
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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
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.
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Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and scope of future clinical trials and results of clinical trials with roluperidone and the further clinical development of MIN-117. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether roluperidone or seltorexant will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the
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Source: Minerva Neurosciences, Inc