Alto Neuro Depression Study Fails

Alto Neuroscience says a Phase 2b study of ALTO-100 in patients with major depressive disorder (MDD) did not meet its primary endpoint, assessed by a change from baseline in a depression rating scale compared to placebo. The company expects to complete its analysis of the full data set before deciding on next steps, if any, to further evaluate ALTO-100 in MDD. It notes that the study saw a favorable safety and tolerability profile of the drug, which was consistent with previously reported studies.

The placebo-controlled study was designed to evaluate ALTO-100 in adults with MDD, “defined by an objective, memory based cognitive biomarker assessed prior to randomization,” Alto says. The biomarker-defined MDD patient group did not demonstrate a statistically significant improvement in depressive symptoms compared to placebo, it says, adding that it also did not demonstrate benefit over placebo on the pre-specified key secondary analyses.