Neurocrine declares positive Phase II trial results for NBI-1065845

Neurocrine Biosciences reports positive findings from the Phase II SAVITRI trial of NBI-1065845 for major depressive disorder (MDD) in adults.

NBI-1065845, an investigational compound, acts as a positive allosteric modulator (PAM) of alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA), targeting MDD patients with inadequate responses to prior treatments.

The trial, involving 183 adults with MDD, was randomized, double-blind, and placebo-controlled. It met primary and key secondary endpoints, showing significant reductions in Montgomery Åsberg Depression Rating Scale (MADRS) total scores at day 28 (primary) and day 56 (secondary) with once-daily oral NBI-1065845.

Compared to placebo, NBI-1065845 exhibited noteworthy improvements, with reductions of -4.3 (p-value = 0.0159) at day 28 and -7.5 (p-value = 0.0016)at day 56 for one dosage, and reductions of -3.0 (p-value = 0.0873) at day 28 and -3.6 (p-value = 0.1082) at day 56 for another dosage.

NBI-1065845 demonstrated good tolerability, with headaches being the most commonly reported adverse event.

Neurocrine collaborates with Takeda in NBI-1065845's development.