Minerva tanks as it abandons MIN-117 in MDD

Clinical stage US biotech Minerva Neurosciences (Nasdaq: NERV) yesterday announced disappointing Phase IIb 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, sending the firm’s shares plunging 27.4% to $5.00 in pre-market trading today.

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 six-week treatment period.  Patients treated with the 2.5mg 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 six weeks of treatment and two weeks of follow-up were 37% for the 2.5mg, 39% for the 5mg, and 38% for placebo. Only headaches were reported at ≥5% in this study at 12% for both the 2.5mg and 5mg, and 7% for placebo.  There were no deaths, and only five patients in total discontinued from the study due to TEAE (two for 2.5mg, one for 5mg, and two for placebo).