Alto Neuroscience (NYSE: ANRO) has initiated its Phase 2b randomized, placebo-controlled trial of ALTO-207 in treatment-resistant depression (TRD), a program designed to replicate the strongly positive PAX-D study results and support a streamlined path to registration.
In the U.S. alone, TRD is estimated to affect approximately seven million adults who do not respond to current antidepressant therapies.
In a statement, Amit Etkin, MD, PhD, founder and CEO of Alto, commented, “We are excited to be initiating this Phase 2b trial, which builds on one of the strongest efficacy signals observed in treatment-resistant depression. ALTO-207 is uniquely designed to build on the robust efficacy demonstrated with pramipexole while addressing the significant tolerability drawbacks that limit its use in clinical practice today. This study is designed like a registrational trial, and we believe it positions us to advance ALTO-207 efficiently.”
