Alto Neuroscience Advances ALTO-207 Into Phase 2b For Treatment-Resistant Depression; Targeting Accelerated Path To Registration
— Phase 2b closely resembles PAX-D study design, which demonstrated an effect size for pramipexole more than two times larger than approved TRD therapies —
— Trial design and MADRS primary endpoint aligned with FDA standards in depression, potentially supporting a single Phase 3 registrational pathway —
— Prior Phase 2a demonstrated robust antidepressant effects of ALTO-207 and favorable tolerability —
— Topline data expected in 2H 2027 —
Alto Neuroscience, Inc. (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on precision medicines for neuropsychiatric disorders, today announced the initiation of a Phase 2b randomized, placebo-controlled trial of ALTO-207 in treatment-resistant depression (TRD), a program designed to replicate the strongly positive PAX-D study results and support a streamlined path to registration. TRD is estimated to affect up to 7 million adults in the United States, representing patients who do not respond adequately to current antidepressant therapies.
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