What's Happening?
Alto Neuroscience has announced the completion of patient enrollment in its Phase 2 proof-of-concept clinical trial for ALTO-101, a novel transdermal phosphodiesterase-4 (PDE4) inhibitor. This trial aims to address cognitive impairment associated with schizophrenia (CIAS), a condition affecting nearly all patients with schizophrenia and contributing to long-term disability. The study involves 83 patients across 13 U.S. sites and uses a double-blind, placebo-controlled crossover design to evaluate the effects of ALTO-101 on EEG measures linked to cognitive dysfunction. The primary endpoint is theta-band inter-trial coherence, an EEG measure correlated with cognitive performance. ALTO-101 is delivered via a proprietary transdermal system developed
with MEDRx, designed to improve drug safety and tolerability.
Why It's Important?
The development of ALTO-101 is significant as it targets a major unmet need in treating cognitive impairment in schizophrenia, for which no pharmacologic treatments currently exist. Cognitive deficits in schizophrenia severely impact patients' functional outcomes, affecting their ability to work and maintain social relationships. The success of ALTO-101 could provide a first-of-its-kind treatment, potentially improving the quality of life for millions of patients. The study's biomarker-driven approach, focusing on EEG measures, represents a novel strategy in precision psychiatry, potentially paving the way for more personalized treatment options in neuropsychiatric disorders.
What's Next?
Following the completion of dosing and data analysis, Alto Neuroscience expects to report topline data from the study by the end of the first quarter. These results will guide future development decisions for ALTO-101. If successful, the study could lead to further clinical trials and eventual FDA approval, offering a new treatment option for cognitive impairment in schizophrenia. The company’s approach may also influence future research and development strategies in the field of precision psychiatry.
