Alto Neuroscience Announces Positive Outcome from Phase 2b Major Depressive Disorder Trial Interim Analysis

Alto Neuroscience, Inc. (NYSE: ANRO) made significant strides with its Phase 2b major depressive disorder (MDD) trial as revealed in the latest 8-K filing with the Securities and Exchange Commission. The company disclosed that on February 12, 2025, it issued a favorable press release following the completion of the interim analysis for the ALTO-300 trial.

The interim analysis led to a recommendation to continue the study, aiming for a final analysis sample of approximately 200 patients. The topline results from the trial are anticipated to be available in mid-2026. The company also reported a preliminary estimated cash balance of around $168 million by the end of 2024, expected to provide operational support through 2028.

Alto Neuroscience’s ALTO-300, an adjunctive treatment option for patients with MDD, is being developed to target specific biomarkers via an oral, small molecule that acts as a melatonin agonist and 5-HT2C antagonist. The trial, characterized by an electroencephalogram (EEG) biomarker signature, is double-blind and placebo-controlled (NCT05922878). Patients will receive either ALTO-300 or a placebo in addition to a background antidepressant over a six-week treatment period, with the primary outcome measured as the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.

Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience, expressed optimism regarding the results from the interim analysis, emphasizing the significance of leveraging insights gained from the ALTO-100 trial. The company’s Precision Psychiatry Platform™ uses EEG activity, neurocognitive assessments, and wearable data to identify patients likely to respond to its products.

Alto Neuroscience is dedicated to revolutionizing psychiatric treatments through personalized approaches. Its clinical pipeline includes innovative drug candidates targeting various mental health conditions beyond depression and schizophrenia. For more in-depth information on Alto Neuroscience and its ongoing developments, interested parties are encouraged to visit the company’s official website or connect with them through investor or media contacts provided on their platform.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Alto Neuroscience’s 8K filing here.

Alto Neuroscience Company Profile

Alto Neuroscience, Inc operates as a clinical-stage biopharmaceutical company in the United States. Its product pipeline comprising ALTO-100, which is in phase 2b clinical trial for the treatment of patients with major depressive disorder (MDD); and which is in phase 2a clinical trial for the treatment of post-traumatic stress disorder.