-- Alto Neuroscience (ANRO) said Tuesday it has initiated a Phase 2b trial of its candidate ALTO-207 in treatment-resistant depression.
The randomized, placebo-controlled study is designed to replicate positive results from the previous PAX-D study and streamline the drug's path toward regulatory registration, the company said. ALTO-207 is a novel, modified-release combination of pramipexole and ondansetron, according to the company.
The formulation aims to reduce nausea typically associated with pramipexole, allowing for higher dosing and faster titration, the company said. In an earlier Phase 2a trial, the drug demonstrated a statistically significant improvement in depression symptoms, measured by the Montgomery-Asberg Depression Rating Scale, the company said.
The trial will enroll about 178 adults in the US and UK who have failed multiple prior treatments, the company said. The primary goal is to measure changes in depression scores over an eight-week treatment period, and topline data are expected in H2 of 2027, the company said.
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