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Alto Neuroscience TD Cowen's 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.TD Cowen's 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit summary17 Sep, 2025
Platform and biomarker strategy
Focus on precision psychiatry using biomarkers such as EEG, cognitive tests, and wearables, with machine learning to predict drug outcomes.
Biomarker selection is based on deep biological understanding and data-driven approaches, with prospective replication to ensure reliability.
Regulatory acceptance is strongest for EEG and cognition-based biomarkers, with wearables and genetic data also considered.
FDA enrichment guidelines are followed, using biomarkers to refine inclusion criteria without altering efficacy endpoints.
Biomarker-based go/no-go decisions are embedded in each program to de-risk advancement.
Pipeline overview and program highlights
ALTO-101 (PDE4 inhibitor) targets cognitive impairment in schizophrenia, using EEG biomarkers as primary outcomes; top-line phase IIB data expected in the second half of the year.
ALTO-207 (pramipexole/ondansetron combo) addresses treatment-resistant depression, enabling higher, faster dosing with reduced nausea; phase IIB to start first half next year.
ALTO-300 (agomelatine) is in phase IIB for adjunctive depression treatment, with study upsized after interim analysis and enrollment ongoing.
ALTO-100 targets bipolar depression, selecting patients based on neuroplasticity impairment; all late-stage programs use biomarker-informed patient classification.
Clinical data and trial design
Pramipexole shows strong efficacy in treatment-resistant depression, especially for anhedonia and motivation, with effect sizes up to 1.1 on MADRS.
Combination with ondansetron mitigates pramipexole’s nausea side effect, allowing faster titration and higher dosing.
EEG biomarkers correlate with clinical and behavioral measures of depression, particularly low dopamine states.
ALTO-101’s phase II uses a crossover design with EEG theta response as the primary outcome, aiming to address a major unmet need in schizophrenia.
ALTO-300’s trial was upsized to address site risk and professional patient issues, with rigorous new protocols for patient verification.
ALTO-207: Phase 2B design and pivotal path.
ALTO-300: Impact of new trial rigor on results?
ALTO-101: EEG biomarker as primary outcome?
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Next Alto Neuroscience earnings date
Q3 202512 Nov, 2025
Next Alto Neuroscience earnings date
Q3 202512 Nov, 2025
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Frequently asked questions
Alto Neuroscience Inc. is a clinical-stage biopharmaceutical company based in the United States, focusing on developing precision medicine for psychiatric conditions. The company leverages AI-derived brain biomarkers to tailor psychiatric drug development to individual patients, aiming to improve treatment effectiveness for mental health issues. Their approach integrates detailed patient-specific data to optimize the drug development process. Alto Neuroscience has a range of products in clinical trials targeting conditions such as major depressive disorder and post-traumatic stress disorder. The company is headquartered in Los Altos, California, and its shares are listed on the NYSE under the ticker ANRO.
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