Minerva MDD Treatment Fails Mid-Stage Trial, Company Has No Further Development Plans

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Shares of Minerva Neurosciences are down more than 22% in premarket trading after the company announced late Wednesday that its Phase IIb major depressive disorder (MDD) trial failed to meet primary and key secondary endpoints.

Waltham, Mass.-based Minerva said its experimental candidate MIN-117 in MDD patients who present symptoms of anxious distress missed the mark in the mid-stage study. 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 six-week treatment period as measured by the change in the Montgomery–Åsberg Depression Rating Scale (MADRS), the company said in its announcement. Also, neither dose showed a statistically significant separation from placebo on the key secondary endpoint, which was the reduction of symptoms of anxiety as measured by the Hamilton Anxiety Rating Scale (HAM-A) during that same six-week period. The company did point to one small silver lining in its announcement. Patients treated with the 2.5 mg dose experienced an improvement of 1.6 points compared to placebo at the second-week mark. No other statistically significant separation from placebo on HAM-A was observed.

The asset was generally well-tolerated and only five patients discontinued from the study due to treatment-emergent adverse events.

Remy Luthringer, executive chairman and chief executive officer of Minerva, expressed his disappointment with the outcome of the trial, which he said was “very well executed.” With no real meaningful outcome in the trial, Luthringer said that as of right now, there are no further clinical development plans for MIN-117 in MDD.

MDD affects more than 300 million people across the globe. Depression is listed as the leading cause of disability worldwide and as a major contributor to the overall global burden of disease, according to the World Health Organization. Approximately 16 million Americans are living with MDD. Despite the high numbers of MDD diagnoses in the world, it has proven to be a tough nut to crack for drug developers. The space has seen a number of failures, including Sage Therapeutics late-stage GABA modulator SAGE-217, which failed to distinguish itself in a statistically significant manner from placebo. Earlier this year, Allergan’s rapastinel failed to hit endpoints in three acute studies based on data from an interim analysis. Also, in February, the U.S. Food and Drug Administration rejected Alkermes’ opioid modulator treatment for MDD.

There have been some wins though in the space. Earlier this year, the FDA approved Janssen’s Spravato, an esketamine-based nasal spray for MDD. That approval marked the first new approach for treating refractory major depressive disorder in nearly 50 years.

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