Investigational MDD Drug Shows Favorable Outcome in Interim Analysis
An ongoing phase 2b trial investigating adjunctive ALTO-300 in patients with major depressive disorder (MDD) and inadequate antidepressant response announced a"favorable outcome" at interim analysis and will add 50 participants after results from a planned interim analysis showed favorable findings, Alto Neuroscience recently announced.
ALTO-300 is an oral, small molecule designed to act as a melatonin agonist and 5-HT2C antagonist. The investigational drug is being developed in the United States as an adjunctive treatment for patients with MDD and a specific electroencephalogram (EEG) biomarker characterized by reduced medial prefrontal neural connectivity.
Prior to the interim analysis, an in-depth site and patient eligibility review by a blinded committee resulted in the prospective exclusion of sites and patients from the analysis population. After the eligibility review, the interim analysis consisted of 87 patients positive for the EEG biomarker.
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The double-blind study (NCT05922878) is randomizing patients with MDD, an inadequate response to antidepressant therapy, and the biomarker to adjunctive treatment with ALTO-300 or placebo over 6 weeks. The primary outcome is the change from baseline on the Montgomery-Åsberg Depression Rating Scale.
The final analysis sample is expected to include approximately 200 biomarker-positive patients. Topline results from the trial are expected in mid-2026, according to the company.
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