Alto Neuroscience, Inc. announced the completion of enrollment in its Phase 2b study of ALTO-100 in adults with major depressive disorder (MDD). Topline results from this study are expected to be reported in October 2024. The Phase 2b study is a randomized, double-blind, placebo-controlled study evaluating ALTO-100 in adults with major depressive disorder (MDD).

The study is designed to determine the efficacy of ALTO-100 in MDD patients defined by an objective cognitive biomarker assessed prior to randomization. The Phase 2b study is enriched for patients exhibiting the predictive cognitive marker but also includes patients without the marker. The primary endpoint is the change from baseline to the end of the 6-week double-blind treatment period on the Montgomery-Åsberg Depression Rating Scale (MADRS), which is the standard regulatory endpoint in depression, in the prospectively identified patient population based on a specific memory deficit.

The study was conducted across 34 sites in the U.S. and enrolled 300 adults with MDD.