– Compelling PAX-D results guided Alto’s acquisition of ALTO-207, designed to induce rapid antidepressant effects while mitigating dose-limiting adverse events of pramipexole –
– Alto plans to collaborate with National Health Service, PAX-D clinical sites for the planned Phase 2b trial of ALTO-207, designed to be a potentially pivotal study; trial expected to initiate by mid-2026 –
Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today highlighted The Lancet Psychiatry publication of data from the PAX-D study evaluating pramipexole in patients with treatment-resistant depression (TRD).The study was conducted by the University of Oxford and was funded by the UK government’s National Institute for Health and Care Research. Results showed pramipexole augmentation of antidepressant treatment, at a target dose of 2.5mg, demonstrated a large (Cohen’s d=0.87) reduction in symptoms relative to placebo at 12 weeks, but was associated with a high rate of adverse effects. The link to the online publication can be found here. The PAX-D study results guided Alto’s acquisition of ALTO-207, a fixed-dose combination of pramipexole and the antiemetic, ondansetron.
“Publication in an esteemed peer-reviewed journal like The Lancet Psychiatry underscores the significance of these findings and therapeutic potential of ALTO-207 to address a critical gap in TRD,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “ALTO-207 is designed to consistently achieve rapid antidepressant effect through faster titration, while mitigating the dose-limiting nausea and vomiting experienced with pramipexole alone. As we prepare to initiate our potentially pivotal, Phase 2b trial by mid-2026, we look forward to drawing on our proprietary insights on dopamine biomarkers in depression and partnering with the National Health Service network, including PAX-D sites to expand our clinical footprint and maximize the likelihood of success.”
The PAX-D sites are supported by the National Institute for Health and Care Research (NIHR) Mental Health Translational Research Collaboration (MH-TRC) mission.
Michael Browning, DPhil, MB.BS, MRCP, MRCPsych, Professor of Computational Psychiatry, University of Oxford, and lead study author added, “As a physician, I am encouraged by the robust and durable clinical effects seen for pramipexole in patients with TRD. While pramipexole may offer greater antidepressant effects than other available TRD treatments, the slow titration aimed at mitigating dose-limiting AEs is likely to hinder adoption. These results make it clear that optimizing tolerability to overcome current barriers may lead to a paradigm shift in treatment.”
Professor Browning presented results from The Lancet Psychiatry publication during Alto’s recent investor conference call to discuss the acquisition of ALTO-207. A replay of the webcast is accessible on the Company’s website here.
