Vistagen therapeutics, inc. reports topline phase 2 results for av-101 as an adjunctive treatment of major depressive disorder

Vistagen therapeutics announced topline results from the elevate study, a phase 2 study of av-101, its nmda (n-methyl-d-aspartate) receptor glycine site antagonist, as an adjunctive treatment of major depressive disorder (mdd). in this study, the av-101 treatment arm did not differentiate from placebo on the primary endpoint (change in the montgomery-Åsberg depression rating scale (madrs-10) total score compared to baseline). as in prior clinical studies, av-101 was well tolerated, with no psychotomimetic side effects or serious adverse events. the elevate study was a phase 2, double-blind, placebo-controlled, multi-center, sequential parallel comparison design (spcd) study that evaluated the safety, tolerability, and efficacy of av-101 as an adjunctive treatment in patients with mdd who had an inadequate response to a stable dose of standard antidepressant therapy (either a selective serotonin reuptake inhibitor (ssri) or a serotonin norepinephrine reuptake inhibitor (snri)). the study randomized 199 patients across 25 clinical research centers in the united states. consistent with the spcd, the study was conducted in two, two-week sequential stages. eligible subjects continued receiving their ssri or snri antidepressant at a stable dose for the duration of the study. patients were randomly assigned (1:3) to av-101 1440 mg/day or placebo in stage 1. placebo non-responders (defined as a < 50% reduction from baseline in madrs-10 total score at the end of stage 1) were re-randomized (1:1) in stage 2 to receive av-101 1440 mg/day or placebo for 2 weeks. the primary efficacy endpoint was the absolute change from baseline to end of treatment in the madrs-10 score of av-101 compared to placebo, both in combination with ongoing therapy with an ssri or snri. treatment differences from stage 1 and stage 2 were combined as weighted averages.
VTGN Ratings Summary
VTGN Quant Ranking