Alto Neuroscience Reports Positive Interim Results for ALTO-300 Phase 2b Depression Trial

Alto Neuroscience, Inc., a company dedicated to developing innovative precision medicines for neuropsychiatric conditions, recently shared positive developments from an interim analysis of its Phase 2b trial involving ALTO-300. This trial is evaluating ALTO-300 as an additional treatment for individuals suffering from major depressive disorder (MDD). As per the interim findings, the trial is set to continue, with an increase of around 50 additional biomarker-positive participants for the final analysis. The results from this study are anticipated by mid-2026.

Dr. Amit Etkin, the founder and CEO of Alto Neuroscience, remarked that the interim analysis represents a significant advancement for the ALTO-300 program. The insights gained from this analysis draw on data from the previous ALTO-100 Phase 2b trial, and the company is optimistic about the outcomes. They are eager to present the topline data in the middle of 2026.

Before conducting the interim analysis, a blinded committee thoroughly reviewed site and patient eligibility, which led to certain sites and patients being excluded from the analysis. The interim analysis comprised 87 patients identified as biomarker-positive. This study is designed as a double-blind, placebo-controlled trial (NCT05922878), enrolling participants identified by an electroencephalogram (EEG) biomarker signature. The company aims to have about 200 biomarker-positive patients for the final analysis. Participants are randomly assigned to receive either ALTO-300 or a placebo, alongside a background antidepressant, over a six-week treatment period. The primary objective is to assess the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.

ALTO-300 is an oral, small molecule that functions as a melatonin agonist and 5-HT2C antagonist. It is being developed in the United States as an adjunctive therapy for MDD patients characterized by an EEG biomarker.

Alto Neuroscience is a clinical-stage biopharmaceutical company aiming to transform psychiatry by using neurobiology to develop personalized and effective treatment options. The company's Precision Psychiatry Platform™ evaluates brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to determine which patients are more likely to respond positively to Alto's drug candidates. Alto's pipeline includes novel treatments for depression, schizophrenia, and other mental health conditions.