Minerva Neurosciences announced its phase 2b trial of MIN-117 in adult patients with moderate to severe major depressive disorder (MDD), and presenting with symptoms of anxious distress failed to meet its primary and key secondary endpoints. Based on these results, the company will discontinue the development of MIN-117 for MDD.
The phase 2b trial was a 6-week, 3-arm, randomized, double-blind, placebo-controlled trial to investigate the safety and efficacy of MIN-117 in 360 adult patients. The 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 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) compared to placebo. Neither dose of MIN-117 showed a statistically significant separation from placebo on the primary endpoint. In addition, neither dose showed a statistically significant separation from placebo on the key secondary endpoint reduction of symptoms of anxiety as measured by the Hamilton Anxiety Rating Scale (HAM-A) over the 6-week treatment period.
MIN-177 has a differentiated mechanism of action targeting adrenergic alpha 1a, alpha 1b, 5-HT1A, 5-HT2A receptors, serotonin, and the dopamine transporter. MIN-117 is meant to block a specific subtype of serotonin receptor called 5-HT1A. When 5-HT1A is blocked, anxiety and mood can be regulated. In addition, MIN-117 is meant to prevent the reuptake of serotonin and dopamine, which increases the amount of serotonin and dopamine in the brain, which is tied to an improvement in mood in individuals suffering from MDD. MIN-117 is also meant to modulate the levels of Alpha-1a and 1b, which further modulates serotonin and dopamine.