– New data support the development of ALTO-101, a novel brain-penetrant phosphodiesterase 4 inhibitor, for the treatment of cognitive impairment associated with schizophrenia –
– Alto identified, and successfully replicated, clinically relevant biomarkers for ALTO-300 and ALTO-100 in independent patient groups within major depressive disorder (MDD) –
– Large phase 2a studies of ALTO-300 and ALTO-100 demonstrated positive results; both product candidates are being evaluated in ongoing Phase 2b randomized placebo-controlled studies in MDD –
LOS ALTOS, Calif., December 7, 2023 – Alto Neuroscience, Inc. today announced details from three presentations on clinical development programs presented at the 62nd annual meeting of the American College of Neuropsychopharmacology (ACNP) that took place in Tampa, Florida, from December 3-6, 2023.
Alto’s data demonstrate advancements in biomarker identification for precision psychiatry and the potential to improve upon the trial-and-error approach to mental health treatment. The company’s AI-enabled Precision Psychiatry Platform™ is designed to predict clinical response and match each patient to the right Alto product candidate through identifying, and prospectively replicating, brain biomarkers by analyzing data generated from EEG activity, neurocognitive task performance, wearable devices, and other measures.
“A precision approach could potentially address the treatment gap for patients living with depression and other difficult-to-treat mental health conditions,” said Maurizio Fava, MD, Psychiatrist-In-Chief, Massachusetts General Hospital, Executive Director, Clinical Trials Network and Institute, and Associate Dean for Clinical and Translational Research, Harvard Medical School. “Understanding the underlying biological mechanisms of psychiatric disease and associated brain biomarkers may finally enable quantifiable data to guide diagnoses and targeted treatments.”
The details of each presentation were as follows:
Presentation Title: Identification and prospective replication of brain/behavior-based pro-cognitive pharmacodynamic effects for ALTO-101: Results from a randomized, double-blind phase 1 study
Presenting Author: Amit Etkin, M.D., Ph.D., founder, president, and chief executive officer
Poster Authors: Akshay Ravindran, Guhan Sundar, Samantha Goncalves, Chao Wang, Li Shen, Maimon Rose, Joshua T. Jordan, Nicholas J. Cooper, Sebastian Marquez, Faizan Badami, Wei Wu, Amit Etkin, Adam J. Savitz
Presentation Highlights:
Presentation Title: Identification and prospective replication of an EEG biomarker for predicting the antidepressant effect of ALTO-300 in patients with Major Depression: Results from large Phase 2a studies
Presenting Author: Adam J. Savitz, M.D., Ph.D., chief medical officer
Poster Authors: Maimon Rose, Joshua T. Jordan, Chao Wang, Faizan Badami, Jessica Powell, Fadi Abdel, Wei Wu, Amit Etkin, Adam J. Savitz
Presentation Highlights:
Presentation Title: Identification and prospective replication of a cognitive biomarker for predicting the antidepressant effect of ALTO-100, a novel pro-plasticity drug, in patients with Major Depression: Results from a large Phase 2a study
Presenting Author: Joshua T. Jordan, Ph.D., senior research scientist
Poster Authors: Joshua T. Jordan, Nicholas J. Cooper, Faizan Badami, Jessica Powell, Wei Wu, Amit Etkin, Adam J. Savitz
Presentation Highlights:
Alto is evaluating ALTO-100 and ALTO-300, stratified by their relevant biomarkers, in Phase 2b studies in MDD, with topline data expected in the second half of 2024 and first half of 2025, respectively. Additionally, Alto is advancing ALTO-101 into a Phase 2 proof of concept study in patients with cognitive impairment associated with schizophrenia, with topline data expected in 2025.
About Alto Neuroscience
Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive task performance, wearable data, and other factors to match each patient with the right Alto product candidate. The company’s work in validating brain-based biomarkers has resulted in a multiple modality approach that supports robust drug-response predictions. Alto’s clinical-stage pipeline includes novel drug candidates in depression, PTSD, schizophrenia, and other mental health conditions. For more information, visit www.altoneuroscience.com or follow Alto on X (Twitter).
Investor Contact
Nick Smith
corporate@altoneuroscience.com
Media Contact
Jordann Merkert
media@altoneuroscience.com