A Phase IIa study of Alto Neuroscience’s ALTO-100 has demonstrated clear evidence of efficacy and a favourable safety record 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.
The Phase II study used 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. Topline data from the Phase IIb study is anticipated to be available in the first quarter of 2024.
“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 Amit Etkin, founder and Chief Executive Officer of Alto Neuroscience.
The eight-week study to evaluate the efficacy and safety of ALTO-100 in patients with MDD or post-traumatic stress disorder (PTSD) involved 133 patients with primary MDD and 95 patients with primary PTSD.
Adam Savitz, Chief Medical Officer of Alto Neuroscience, added: “We are encouraged by the potential of these results to redefine the treatment paradigm in depression, which today is largely dependent upon trial-and-error.”