BRIEF—Positive results for ALTO-100 in MDD

USA-based Alto Neuroscience has reported results from its Phase IIa study of ALTO-100, demonstrating clear evidence of efficacy and favorable safety in patients with major depressive disorder (MDD).

In the study, patients with a biomarker profile that ties back to a mechanistic understanding of ALTO-100 and depression exhibited a significantly greater change in Montgomery–Åsberg Depression Rating Scale (MADRS) scores and response rates than those without the biomarker profile.

This first-of-its-kind Phase II study leveraged Alto’s Precision Psychiatry Platform to identify likely drug responders based on an understanding of biological heterogeneity in depression and ALTO-100’s novel mechanism.

The results support the initiation of ALTO-100 into a large Phase IIb trial in patients with biomarker-defined MDD in January 2023.

“The strength of these results demonstrates, for the first time, that we can prospectively identify likely responders to our novel drugs and apply data-driven measurement to the treatment of psychiatric and other central nervous system disorders,” said Dr Amit Etkin, founder and chief executive of Alto Neuroscience.