Alto Neuroscience’s Phase 2b study of ALTO-100 did not meet primary endpoint

Alto Neuroscience (ANRO) “announced that the Phase 2b study of ALTO-100 in patients with major depressive disorder did not meet its primary endpoint, assessed by a change from baseline in Montgomery-Asberg Depression Rating Scale, compared to placebo. The favorable safety and tolerability profile of ALTO-100 was consistent with previously reported studies. The randomized, double-blind, placebo-controlled Phase 2b study was designed to evaluate ALTO-100 in adults with MDD, defined by an objective, memory based cognitive biomarker assessed prior to randomization. The primary endpoint was the change from baseline to the end of the 6-week double-blind treatment period on the MADRS, which is the standard regulatory endpoint in depression. The study was conducted across 34 sites in the U.S. and enrolled 301 adults with MDD. The biomarker-defined MDD patient group treated with ALTO-100 did not demonstrate a statistically significant improvement in depressive symptoms compared to placebo. ALTO-100 did not demonstrate benefit over placebo on the pre-specified key secondary analyses. ALTO-100 continued to demonstrate a favorable safety and tolerability profile, with no new safety signals observed in this study as compared to the previously completed clinical trials of ALTO-100. The most common adverse events from the trial related to treatment with ALTO-100 were headache, nausea, and abnormal dreams – all of which were experienced at similar rates to placebo. The Company expects to complete analysis of the full data set to determine the most appropriate next steps, if any, to further evaluate ALTO-100 in MDD.”