Alto Neuroscience Submits IPO Filing Highlighting ALTO-300 Phase 2a Success in Biomarker-Guided Depression Therapy

▎Edited by the WuXi AppTec content team

Alto Neuroscience Announces Positive Results from Phase 2a Clinical Trial of ALTO-300 for Major Depressive Disorder (MDD) at the 62nd Annual Meeting of the American College of Neuropsychopharmacology (ACNP)

This 8-week clinical trial aims to evaluate the efficacy and safety of ALTO-300 as an adjunctive treatment for patients with MDD. The study enrolled 239 participants aged between 18 and 74 who added ALTO-300 while continuing their existing antidepressant therapies. Among them, 110 patients underwent baseline EEG assessments. Using a machine learning-driven data science approach, Alto Neuroscience prospectively predicts the antidepressant effects of the drug through biomarkers. This method aims to ensure accurate identification of patients likely to respond to the treatment.

The main findings of the Phase 2a clinical trial for ALTO-300 include:

Identify a repeatable, scalable, and easily manageable machine learning-based EEG biomarker.

Alto is using this biomarker in its Phase 2b trial of ALTO-300 to prospectively identify patients who may benefit.

In the overall dataset, patients identified by biomarkers (n=55) showed an average reduction of 8.3 points in MADRS at Week 1 compared to the group without biomarkers (n=48) (p=0.03), with continued improvement at Week 8 (-17 vs. -12.3, p=0.002).

At week 4, a greater proportion of patients identified through biomarkers achieved clinical remission (defined as a ≥50% reduction in depressive symptoms) compared to those without biomarkers, at 47% versus 27%, and this trend persisted at week 6 (58% vs. 34%) and week 8 (62% vs. 47%).

ALTO-300 demonstrated good safety and tolerability, with no reports of unexpected side effects.

Dr. Amit Etkin, CEO of Alto Neuroscience, told the content team of WuXi AppTec in an interview that he hopes precision psychology therapies that screen patients through biomarkers can transform the new drug development model in the field of mental illness. It is expected that in the next five years, one or more therapies for mental and neurological diseases guided by biomarkers may gain regulatory approval or enter late-stage clinical trials.

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