What's Happening?
Alto Neuroscience, a clinical-stage biopharmaceutical company, has announced the completion of patient enrollment in its Phase 2 proof-of-concept clinical trial for ALTO-101. This novel transdermal phosphodiesterase-4
(PDE4) inhibitor is being evaluated for its effectiveness in treating cognitive impairment associated with schizophrenia (CIAS). The trial enrolled 83 patients across 13 clinical sites in the United States. The study is designed as a randomized, double-blind, placebo-controlled crossover trial to assess the impact of ALTO-101 on electroencephalography (EEG) measures linked to cognitive dysfunction in schizophrenia. Participants receive 10 days of treatment with either ALTO-101 or a placebo, followed by a washout period, and then switch to the opposite treatment. The primary endpoint is theta-band inter-trial coherence (ITC), an EEG measure correlated with cognitive performance.
Why It's Important?
Cognitive impairment is a significant and persistent feature of schizophrenia, affecting nearly all patients and contributing to long-term functional disability. Currently, there are no approved pharmacologic treatments for CIAS, highlighting a substantial unmet medical need. ALTO-101, with its novel transdermal delivery system, aims to address this gap by providing a treatment option that mitigates gastrointestinal side effects while maintaining central nervous system engagement. The successful completion of this trial could lead to a first-of-its-kind treatment for the cognitive deficits associated with schizophrenia, potentially improving the quality of life for millions of patients.
What's Next?
Topline data from the Phase 2 study are expected following the completion of dosing and data analysis. These results will guide future development decisions for ALTO-101. If successful, the study could pave the way for further clinical trials and eventual regulatory approval. Alto Neuroscience's approach, which includes a biomarker-driven strategy, may also influence future research and development in the field of neuropsychiatric disorders.
