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# Alto Neuro Depression Study Fails
- URL: https://www.fdaweb.com/alto-neuro-depression-study-fails/
- Published: 2024-10-23T12:00:00.000Z
- Updated: 2026-09-14T14:44:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158037

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.