Wellcome Trust Funds Alto Neuroscience for ALTO-100 Development in Bipolar Depression Using Precision Psychiatry

Alto Neuroscience, Inc., a clinical-stage biopharmaceutical company based in Mountain View, California, has received a grant of $11.7 million from the Wellcome Trust to support the clinical development of its leading candidate, ALTO-100. This funding will facilitate a Phase 2b study aimed at patients with bipolar depression, particularly those identified through a specific cognitive biomarker. The study has begun, with topline results anticipated in 2026.

Bipolar depression, a particularly challenging psychiatric condition, currently has limited treatment options that often involve antipsychotics known for their limited effectiveness and significant side effects. Amit Etkin, M.D., Ph.D., the founder and CEO of Alto Neuroscience, emphasized the association between bipolar depression and abnormalities in memory, cognition, and neuroplasticity. ALTO-100, which operates through a pro-neuroplasticity mechanism, offers a potential new treatment for patients who exhibit similar neurobiological profiles. Etkin expressed gratitude to the Wellcome Trust for their commitment to addressing bipolar depression and accelerating Alto's late-stage clinical program. This support aims to develop the first precision treatment for bipolar disorder.

Dr. Lynsey Bilsland, Head of Mental Health Translation at Wellcome, reiterated their commitment to advancing mental health research and innovation for early intervention. She noted the potential significant impact of Alto’s precision psychiatry drug candidate on patients with bipolar depression and other mental health conditions. Dr. Bilsland stressed the importance of supporting initiatives that promote targeted treatment approaches, moving away from the traditional trial-and-error methods in the industry.

ALTO-100, an oral small molecule, is believed to enhance neural plasticity and is currently under Phase 2b development for major depressive disorder (MDD). Topline results for this study are expected in October 2024. Previous Phase 2a studies of ALTO-100 in MDD and post-traumatic stress disorder (PTSD) showed favorable safety and tolerability, with patients exhibiting a memory-based cognitive biomarker responding better to the treatment.

The ongoing Phase 2b study for ALTO-100 in MDD uses the same memory biomarker and study design. This randomized, double-blind, placebo-controlled study will include around 200 adults with bipolar depression, evaluated over a six-week treatment period. The primary endpoint will be the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS), consistent with the endpoint used in the ongoing Phase 2b MDD study and other registrational studies in bipolar depression.

Alto Neuroscience is dedicated to revolutionizing psychiatry by using neurobiology to create personalized and effective treatment options. Their Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors, aiming to identify patients likely to respond to Alto’s products. The company's pipeline includes drug candidates targeting depression, PTSD, schizophrenia, and other mental health disorders.

ALTO-100 is a novel oral small molecule that has shown promise in promoting neuroplasticity, with potential as a first-in-class therapeutic option. It is being developed for conditions like major depressive disorder and bipolar depression, which currently lack treatments targeting cognitive symptoms. In prior Phase 2a trials, ALTO-100 demonstrated good safety and tolerability, with significant treatment responses in patients identified through a cognitive biomarker.

Alto uses its Precision Psychiatry Platform™ to identify brain-based biomarkers that predict patient response to medication. The identified predictive biomarker for ALTO-100, a verbal memory test, directly measures hippocampal neuroplasticity. This test, a digital adaptation of a well-validated memory assessment tool, is reliable and can be self-administered in under 20 minutes in various settings, facilitating broad clinical data collection.

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