Clinical-stage biopharmaceutical company Alto Neuroscience Inc (NYSE:ANRO) announced on Friday that the US Food and Drug Administration (FDA) has granted Fast Track designation to ALTO-101 for the treatment of cognitive impairment associated with schizophrenia (CIAS).

CIAS is a core feature of schizophrenia with no currently approved treatments, significantly affecting daily functioning and quality of life.

ALTO-101 is a novel phosphodiesterase-4 (PDE4) inhibitor that has shown pro-cognitive effects in healthy volunteers. By inhibiting PDE4, ALTO-101 increases cAMP levels in the brain, potentially enhancing neuronal signalling and synaptic plasticity, which are critical to learning and memory.

Fast Track designation is intended to accelerate the development and review of therapies for serious conditions with unmet medical needs. This status may allow for more frequent FDA interactions and potential eligibility for accelerated approval and priority review.

ALTO-101 is currently being evaluated in an ongoing Phase 2 proof-of-concept study in patients with CIAS.