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Alto Neuroscience (NYSE:ANRO) announced the completion of enrollment in its Phase 2b study evaluating ALTO-100 in 300 adults with major depressive disorder (MDD) across 34 U.S. sites.
The randomized, double-blind, placebo-controlled study is designed to determine the efficacy of ALTO-100 in MDD patients, defined by an objective cognitive biomarker assessed prior to randomization. The study is enriched for patients exhibiting the predicative cognitive marker but also includes patients without the marker.
In a statement, Amit Etkin, M.D., Ph.D., founder and CEO of Alto, said, “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.”
Alto’s CMO, Adam Savitz, M.D., Ph.D., added, “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. The execution of this study demonstrates the potential for this test to be implemented broadly in clinical practice. We are grateful to the patients in the study, physicians, trial site staff, and partnerships with advocacy organizations for their efforts in helping us to reach this point.”