Arena Pharmaceuticals, a San Diego-based biopharmaceutical company focused on novel drugs for weight management, cardiovascular disease, inflammation and other disorders, has initiated dosing in a phase I multiple dose clinical trial of APD811, a novel oral drug candidate discovered by Arena that targets the prostacyclin (IP) receptor for the treatment of pulmonary arterial hypertension (PAH).
This randomized, double-blind and placebo-controlled dose titration trial is planned to enroll up to 30 healthy adult volunteers, and will evaluate the safety, tolerability and pharmacokinetics of multiple-ascending doses of APD811 and the optimal titration schedule. Arena previously evaluated single-ascending doses of APD811 in the initial phase I clinical trial.
"Treatment with prostacyclin receptor agonists is considered standard of care for advanced PAH, but approved drugs in this class require intravenous, subcutaneous or inhaled delivery methods," said William R. Shanahan, M.D., senior vice president and CMO, Arena. "APD811 has the potential to improve treatment for this life-threatening disorder by providing patients with an oral, once-daily option targeting the prostacyclin receptor. This drug candidate was discovered internally by our scientists as part of our effort to bring best-in-class treatments to patients."