Alto Neuroscience Announces Enrollment Completion in Phase 2b Study of ALTO-100 in Major Depressive Disorder

– 300 patients enrolled in the study, including patients with and without the cognitive biomarker –

– On track to report topline data in October 2024 –

– Alto to host investor day focused on ALTO-100 on September 9, 2024 –

Excerpt from the Press Release:

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)– Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced the completion of enrollment in its Phase 2b study of ALTO-100 in adults with major depressive disorder (MDD). Topline results from this study are expected to be reported in October 2024.

“The completion of enrollment in this study marks an important achievement,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “We look forward to reporting topline results later this year, which, if positive, will propel us into Phase 3 and ultimately bring us one step closer to realizing the potential of precision psychiatry.”

The Phase 2b study is a randomized, double-blind, placebo-controlled study evaluating ALTO-100 in adults with major depressive disorder (MDD). The study is designed to determine the efficacy of ALTO-100 in MDD patients defined by an objective cognitive biomarker assessed prior to randomization. The Phase 2b study is enriched for patients exhibiting the predictive cognitive marker but also includes patients without the marker. The primary endpoint is the change from baseline to the end of the 6-week double-blind treatment period on the Montgomery-Åsberg Depression Rating Scale (MADRS), which is the standard regulatory endpoint in depression, in the prospectively identified patient population based on a specific memory deficit. The study was conducted across 34 sites in the U.S. and enrolled 300 adults with MDD. For more information about the ongoing study, visit ClinicalTrials.gov (NCT05712187).

“Major depressive disorder is among the most prevalent CNS conditions and is a leading cause of disability worldwide,” said Adam Savitz, M.D., Ph.D., chief medical officer of Alto. “If we are successful, new targeted therapies like ALTO-100 represent the future of psychiatric care. We are pleased with the receptivity to our neurocognitive test.

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