Alto Neuroscience (ANRO) announced multiple presentations at the Society of Biological Psychiatry annual meeting, in Toronto, Canada, held April 24-26. An EEG-based biomarker capable of predicting non-specific treatment response across multiple interventions and independent datasets was developed and validated. The placebo biomarker yielded significant predictions for the open-label ALTO-100 and sertraline treatment response, both analyzed prospectively. Additional prospective analyses in two randomized-controlled MDD studies were conducted to further validate the previously identified EEG-based placebo biomarker on both placebo response and drug-placebo differences. In the ALTO-100 placebo arm, the biomarker significantly predicted MADRS score change across all weeks with correlation ranging from 0.29 to 0.19 at weeks 2 and 6 respectively. In the EMBARC placebo arm, the biomarker significantly predicted HAMD score change, with a partial correlation ranging from 0.24 to 0.31 at weeks 6 and 8 respectively. Drug-placebo treatment effect sizes were enhanced across diverse drug mechanisms when accounting for individual differences in predicted placebo response, as demonstrated by both the Phase 2b trial of ALTO-100 and EMBARC trial of sertraline. This biomarker has the potential to enable more precise identification of high placebo responders in MDD trials, reduce trial variability, and enhance detection of treatment effects.
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