Alto Neuroscience Receives FDA Fast Track Designation for ALTO-101 for the Treatment of Cognitive Impairment Associated with Schizophrenia

Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to 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 is an FDA process designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track designation may be eligible for more frequent meetings with the FDA to discuss the drug’s development plan, as well as eligibility for accelerated approval and priority review, if relevant 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 chief executive officer 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. The cognitive deficits in schizophrenia, which include impaired attention, memory, and executive function, represent a substantial and underserved aspect of the illness.