Alto Neuroscience (NYSE: ANRO) announced that the FDA has granted its novel small molecule PDE4 inhibitor, ALTO-101, fast track designation for the treatment of cognitive impairment associated with schizophrenia (CIAS).
The company states that 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. Enrolment for a Phase 2 proof-of-concept study of ALTO-101 in patients with CIAS is ongoing.
In a statement, Amit Etkin, MD, PhD, founder and CEO of Alto, commented, “Receiving fast track designation from the FDA underscores the critical need for new, effective treatments for patients suffering from CIAS. 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.”
