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The first patient has been dosed in a phase 2 study evaluating safety and efficacy of AR1001 (AR1001; AriBio, San Diego, CA). A novel phosphodiesterase inhibitor, AR1001, is being investigated for treatment of Alzheimer’s disease (AD).
The 26-week double-blind placebo-controlled study (NCT03625622) in participants with mild-to-moderate AD will use improvement in scores on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-C) and the Alzheimer’s Disease Cooperative Study-clinical global impression of change subscale (ADCS-CGIC) as primary outcome measures. Other neuropsychiatric tests and quality-of-life measures will be used as secondary measures.
Phosphodiesterase inhibitors are thought to inhibit neuronal death and synaptic loss by removing toxic beta-amyloid oligomers.
“Based on the established safety profile of AR1001 and the promising preclinical data, we are hopeful to see a clinically meaningful outcome from this Phase 2 study,” said James Rock, senior vice president of global operations at Aribio. “As the demand for therapeutic advancement for Alzheimer’s disease and other neurodegenerative diseases rapidly grows, we are strongly committed to expanding our AR1001 program with additional indications and advancing several back-up candidates in our pipeline.”
Matthew Varon, MD; and Pedro M. Machado, MD, PhD
Michelle L. Dougherty, MD, FAAN, FAES
Wijdan Rai, MD; and Bakri Elsheikh, MBBS