Alto Neuroscience has reported positive outcomes from the interim analysis of its double-blind Phase IIb trial of oral ALTO-300, as an adjunctive treatment for major depressive disorder (MDD).
The trial will be extended to include nearly 50 additional subjects who are biomarker-positive in the final analysis sample, anticipating top line outcomes by mid-2026.
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A blinded committee reviewed the site and subject eligibility before this interim assessment, which led to the prospective exclusion of certain sites and subjects from the analysis population.
Post-review, the biomarker-positive cohort for the interim analysis comprised 87 subjects.
The placebo-controlled trial is enrolling subjects identified through an electroencephalogram (EEG) biomarker signature.
Alto aims to include 200 biomarker-positive subjects in the final analysis sample. Subjects are randomised to receive either the therapy or a placebo alongside their current antidepressant, which has not fully addressed their symptoms, over a treatment duration of six weeks.
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from the baseline is the primary result of the trial.
Alto Neuroscience CEO and founder Amit Etkin said: “The outcome of this interim analysis marks an important milestone for the ALTO-300 programme.
“The interim analysis was an opportunity to leverage valuable insight from the completed ALTO-100 Phase IIb trial, and we are encouraged by these results. We look forward to reporting topline data in mid-2026.”
The therapy functions as a 5-HT2C antagonist and melatonin agonist.
A clinical-stage biopharmaceutical company, Alto is focused on employing neurobiology to create personalised treatments.
The company’s Precision Psychiatry Platform is designed to leverage brain biomarkers by analysing neurocognitive evaluations, EEG activity, wearable data, and more, to detect subjects likely to respond to its product candidates.
Its clinical-stage pipeline features drug candidates for schizophrenia and depression, among others.
In April 2024, the company initiated a Phase II trial of ALTO-203, a histamine H3 receptor inverse agonist, targeting MDD patients.
