Shares in Minerva Neurosciences sank as much as 28% Wednesday after the company reported top-line data indicating that MIN-117 achieved neither the primary nor the key secondary endpoints in a Phase IIb trial of adults suffering from moderate-to-severe major depressive disorder (MDD). "We are obviously disappointed with the results," commented CEO Remy Luthringer, adding that "at present, we have no plans for further clinical development of the molecule in MDD."
The study randomly assigned 360 moderate-to-severe MDD patients with symptoms of anxious distress, but no psychotic features, to receive MIN-117 at doses of either 2.5 mg or 5 mg, or placebo. The main efficacy endpoint was change from baseline in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score at the end of the six-week treatment period. Secondary efficacy evaluations included the Hamilton Anxiety Rating Scale (HAM-A), as well as the Clinical Global Impression – Severity (CGI-S) and Clinical Global Impression – Improvement (CGI-I) scales.
Minerva said neither of the tested MIN-117 doses significantly improved depression symptoms versus placebo as measured by MADRS. Similarly, there was no significant separation from placebo on the key secondary endpoint assessing reduction of anxiety symptoms based on the HAM-A index over the six-week treatment period.
The company noted that MIN-117 was generally well-tolerated, and the incidence of patients who reported treatment emergent adverse events (TEAEs) over the duration of six weeks of treatment and two weeks of follow-up were 37% for low-dose MIN-117, 39% for the high-dose group, and 38% for placebo. There were no deaths, and a total of five patients dropped out of the study due to TEAEs.
According to Minerva, MIN-117 has a differentiated mechanism of action targeting adrenergic alpha 1a, alpha 1b, 5-HT1A, 5-HT2A, serotonin and the dopamine transporter. In 2016, the company reported positive results from a Phase IIa study testing MIN-117 at doses of 0.5 mg and 2.5 mg, saying the drug demonstrated dose-dependent superiority over placebo as measured by change in MADRS. Minerva noted at the time that the "magnitude of effect size is similar to those observed with currently marketed antidepressants."
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