Alto Neuroscience (Alto) has reported that its Phase IIb clinical trial of ALTO-100 for treating major depressive disorder (MDD) failed to meet its primary endpoint.
The study aimed to assess ALTO-100 by measuring changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline compared to a placebo.
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This double-blind, randomised, placebo-controlled trial was designed for assessing ALTO-100 in adults diagnosed with MDD, using a memory-based cognitive biomarker for assessment before randomisation.
The primary focus was on the change from baseline to the end of a six-week treatment period using MADRS, which is a standard regulatory endpoint for depression.
Conducted across 34 US sites, the trial enrolled 301 adult subjects with MDD.
The group of patients with biomarker-defined MDD treated with ALTO-100 failed to show a statistically significant improvement in symptoms related to depression, when compared to the placebo group.
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By GlobalDataIn the pre-specified key secondary analyses, the therapy also did not demonstrate a benefit over a placebo.
Alto Neuroscience founder and CEO Amit Etkin said: “We are disheartened by the results from this study as the unmet need in this patient population is immense. While the results are surprising and disappointing, I am proud of our team for conducting a first-of-its-kind precision biomarker-based study in psychiatry.
“We remain committed to our mission of helping patients get better faster by bringing precision medicine to psychiatry, and we expect our strong cash balance to support us through multiple near-term clinical milestones across our pipeline.”
Despite these results, ALTO-100 maintained a favourable tolerability and safety profile, consistent with previous studies, with no new safety signals observed.
Alto is set to complete a full data analysis to determine the future steps for evaluating ALTO-100 in MDD treatment.
In addition to the MDD study, ALTO-100 is being investigated as an adjunctive treatment in a separate Phase IIb study for bipolar depression.
Alto has stated that its current financial position is expected to support operations into 2027, which includes multiple upcoming clinical readouts.
The results for ALTO-203 and ALTO-300 in MDD are anticipated in the first half of 2025.
Earlier this year, Alto commenced a Phase II clinical trial of ALTO-203 for treating MDD.
