Alto Neuroscience’s Schizophrenia Treatment Granted FDA Fast Track Designation

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Alto Neuroscience Inc.’s ALTO-101 for the treatment of cognitive impairment associated with schizophrenia (CIAS). There are currently no approved treatments for CIAS, a core feature of schizophrenia that severely impacts daily functioning and quality of life for millions of patients.

Fast Track designation, an FDA process, expedites drug development for serious conditions with unmet medical needs. Eligible drugs may receive more frequent FDA meetings and accelerated approval or priority review if criteria are met.

“Receiving Fast Track designation from the FDA underscores the critical need for new, effective treatments for patients suffering from cognitive impairment associated with schizophrenia,” said Amit Etkin, M.D., Ph.D., Founder and CEO of Alto Neuroscience. “This designation is a significant milestone for the ALTO-101 program, and we believe it is a testament to its potential as a novel treatment approach. Our Phase 1 data, which demonstrated significant and clinically relevant effects of ALTO-101 on both EEG measures and cognitive performance in healthy subjects, provides strong validation for its mechanism. We are committed to advancing this program expeditiously for the millions of patients who currently have no approved treatment options to address these debilitating cognitive deficits.”

ALTO-101 is a novel small molecule phosphodiesterase-4 (PDE4) inhibitor. The PDE4 enzyme plays a key role in the brain by breaking down cyclic adenosine monophosphate (cAMP), a molecule crucial for neuronal signaling and synaptic plasticity, which are fundamental to learning and memory. By inhibiting PDE4, ALTO-101 increases cAMP levels, which is believed to enhance neural circuits and improve cognitive function.