Alto Neuroscience Presents New Data at the 64th Annual Meeting of the American College of Neuropsychopharmacology
– Data presented demonstrate robust validation of Theta ITC as an EEG biomarker of CIAS and support its use as the primary outcome in the ongoing Phase 2 POC study of ALTO-101 –
– Detailed analysis of data from the completed ALTO-203 Phase 2 proof-of-concept study demonstrates clear pharmacodynamic effects and suggests utility of ALTO-203 in indications with excessive daytime sleepiness and/or deficits in sustained attention –
“We are pleased to have the opportunity to showcase the breadth and depth of our precision psychiatry platform at ACNP, which is one of the most highly regarded conferences in psychiatry,” said
The details of each presentation are as follows:
Presentation Title: Event-Related Theta Responses as Candidate Markers of Cognitive Impairment Associated with Schizophrenia: Independent Replication of Case-Control Differences and Cognitive Associations in a Large
Key Takeaways:
- This new analysis of an independent data set consisting of 155 individuals with schizophrenia and 272 healthy control subjects validated the prior findings by Alto supporting Theta-ITC as the most robust EEG marker for detecting case-control differences.
- Theta-ITC shows consistent association with key cognitive measures being evaluated in Alto’s ongoing CIAS trial.
- The results represent a second large independent replication and further strengthen the relevance of Theta-ITC as a key biomarker endpoint to evaluate potential effects in CIAS.
Presentations Title: Prospective replication of an EEG biomarker for predicting changes in attention with ALTO-203, an H3 inverse agonist
Key Takeaways:
- ALTO-203 improves sustained attention, decreases theta/beta ratio, and the greatest improvements in sustained attention occur in individuals with abnormal theta/beta ratios.
- ALTO-203 improved wakefulness, without changes in sleep efficiency or wake after sleep onset.
- These findings replicate prior data from a Phase 1 study of ALTO-203 in healthy subjects and suggest ALTO-203 may be best suited for indications with excessive daytime sleepiness/hypersomnolence and/or deficits in sustained attention.
Presentation Title: An EEG Biomarker Predicting Placebo Response in Major Depressive Disorder: Development, Prospective Validation, and Implications for Enhancing Detection of Treatment Effects
Key Takeaways:
- Alto developed and validated an EEG biomarker capable of predicting treatment response across various interventions and independent data sets in depression.
- The EEG biomarker was used to analyze data from two randomized controlled trials, which resulted in enhanced treatment effect compared to the analysis without accounting for individual differences.
- These analyses demonstrate the potential to use an EEG biomarker to improve signal detection in studies of interventions in MDD.
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Forward-Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “expects,” “plans,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto’s expectations about the potential benefits, activity, and effectiveness of its product candidates, biomarkers, and Precision Psychiatry Platform (“Platform”); statements regarding Alto’s expectations for the design, progress and results of its ongoing Phase 2 POC trial of ALTO-101 in CIAS; the reproducibility of any favorable results seen in the exploratory Phase 2 POC trial of ALTO-203; and Alto’s expectations with regard to the design and results of its clinical trials. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including uncertainties inherent in the initiation, progress and completion of clinical trials and other important factors, any of which could cause Alto’s actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled “Risk Factors” in Alto’s Quarterly Report on Form 10-Q for the fiscal quarter ended
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