Alto Neuroscience, Inc. announced the identification of a patient selection biomarker and positive pharmacodynamic results from its exploratory Phase 2 proof-of-concept (POC) trial of ALTO-203. The trial focused on major depressive disorder (MDD) patients with elevated levels of anhedonia.
The study identified the EEG high-theta/beta ratio as a robust biomarker for ALTO-203, a measure of abnormal cortical arousal and poor attentional control. This biomarker is notably FDA-cleared for use alongside clinical evaluation in the diagnosis of ADHD, reinforcing its clinical relevance.
ALTO-203, a novel oral histamine H3 inverse agonist, demonstrated clear effects on objective measures of attention and wakefulness, with observed improvements linked to changes in the EEG theta/beta ratio. These findings replicate results from a prior Phase 1 study in healthy volunteers, strengthening the foundation of Alto's precision psychiatry approach.
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