Alto Neuroscience Says FDA Grants Fast Track Designation To ALTO-101 For Treatment Of Cognitive Impairment Associated With Schizophrenia

– ALTO-101, a novel PDE4 inhibitor, has demonstrated pro-cognitive effects in healthy volunteers –

– Designation highlights the significant unmet need for new treatments for cognitive impairment associated with schizophrenia (CIAS) –

– Enrollment remains ongoing in a Phase 2 proof-of-concept study of ALTO-101 in patients with CIAS –

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.