ALTO-101

  • Alto Neuroscience’s ALTO-101 Gets FDA Fast Track for Schizophrenia-Related Cognitive Impairment

    Alto Neuroscience’s ALTO-101, a novel PDE4 inhibitor, received FDA Fast Track designation for treating cognitive impairment associated with schizophrenia (CIAS), a condition with no approved treatments. Phase 1 data showed ALTO-101 improved EEG measures and cognitive performance in healthy volunteers. A Phase 2 proof-of-concept study in CIAS patients is ongoing. The Fast Track designation allows for more frequent FDA communication and potential accelerated approval. Alto uses a Precision Psychiatry Platform to identify patients most likely to respond to their therapies.

    2 days ago