Publication date: Jun 28, 2025
Alto misses primary efficacy endpoint in phase 2 depression trial. Manalac T. Alto digs into exploratory outcomes as depression drug misses phase II endpoint. Alto Neuroscience identifies biomarker and reports positive pharmacodynamic results from exploratory phase 2 proof-of-concept trial of ALTO-203. In this exploratory trial, we identified a robust biomarker for ALTO-203, EEG high-theta/beta ratio, which is a well-validated measure of abnormal cortical arousal and poor attentional control. Patients in the multi-dose part of the trial took ALTO-203 once daily for 28 days. Notably, this biomarker is FDA-cleared for use alongside clinical evaluation in the diagnosis of ADHD, reinforcing its clinical relevance. Obviously, statistical significance is an important cut point there, but also is that signal similar to what we have seen in healthy individuals?
| Concepts | Keywords |
|---|---|
| Adobestockalto | Alto |
| Ceo | Biomarker |
| Depressive | Clinical |
| Fiercebiotech | Depression |
| Drug | |
| Efficacy | |
| Endpoint | |
| Exploratory | |
| June | |
| Misses | |
| Neuroscience | |
| Phase | |
| Positive | |
| Primary | |
| Trial |
Semantics
| Type | Source | Name |
|---|---|---|
| disease | MESH | Major Depressive Disorder |
| disease | MESH | anhedonia |
| disease | MESH | Depression |
| drug | DRUGBANK | Tropicamide |
| disease | MESH | ADHD |
| disease | MESH | clinical relevance |
| pathway | REACTOME | Release |
| drug | DRUGBANK | Coenzyme M |