Alto Neuroscience, Inc. ((ANRO)) announced an update on their ongoing clinical study.
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Alto Neuroscience, Inc. is conducting a study titled ‘A Randomized, Double-Blind, Placebo-Controlled Study Followed by Open-Label Treatment of ALTO-100 in Adults With Bipolar Disorder Currently Experiencing a Major Depressive Episode.’ The study aims to evaluate the antidepressant efficacy of ALTO-100 compared to a placebo in patients with bipolar disorder experiencing a major depressive episode, alongside mood stabilizers or atypical antipsychotics. Safety, tolerability, and efficacy will also be assessed in an open-label phase.
The intervention being tested is ALTO-100, an experimental drug administered as a 40 mg tablet twice daily. It is intended to improve depressive symptoms in bipolar disorder patients.
This Phase 2 study is designed as a randomized, double-blind, placebo-controlled trial with a parallel intervention model. It involves quadruple masking, meaning participants, care providers, investigators, and outcomes assessors are unaware of the treatment allocations. The primary purpose is treatment-focused.
The study began on October 15, 2024, with the primary completion date yet to be announced. The latest update was submitted on July 11, 2025, indicating ongoing recruitment.
This study update could influence Alto Neuroscience’s stock performance, as positive results may enhance investor confidence and market position. The competitive landscape in bipolar disorder treatments is significant, with many companies vying for effective solutions.
The study is ongoing, with further details available on the ClinicalTrials portal.