Alto Neuroscience initiates Phase 2 study of ALTO-101

Alto Neuroscience announced the initiation of a Phase 2 double-blind, placebo-controlled study of its transdermal formulation of ALTO-101, a novel PDE4 inhibitor in development for the treatment of cognitive impairment associated with schizophrenia. Alto expects to report top-line data from the Phase 2 study in the second half of 2025. “We are excited to initiate our sixth Phase 2 study as a company, across our pipeline programs, as we continue to redefine mental healthcare with Alto’s Precision Psychiatry Platform,” said Amit Etkin, M.D., Ph.D., founder and CEO of Alto Neuroscience. “Cognitive impairment is disabling in many psychiatric disorders including schizophrenia, depression, and neurodegenerative diseases. ALTO-101 has the potential to address the cognitive aspects of these diseases with a known pro-cognitive mechanism, while also overcoming the side effects typically associated with PDE4 inhibitors. We look forward to completing this proof-of-concept study, as we believe ALTO-101 may benefit patients with CIAS and potentially become an important therapeutic option for a broad range of indications.”