Biopharmaceutical company Arena Pharmaceuticals has begun dosing in its placebo-controlled Phase I multiple-dose clinical trial of APD811 for pulmonary arterial hypertension (PAH).
The randomised, dose titration trial is designed to evaluate the safety, tolerability and pharmacokinetics of multiple-ascending doses of the drug and the optimal titration schedule.
The double-blind trial will enrol up to 30 healthy adult volunteers, said the company
Arena senior vice president and chief medical officer Dr William Shanahan said the approved drugs considered standard of care for advanced PAH require intravenous, subcutaneous or inhaled delivery methods.
"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," Shanahan said.
The APD811 is an orally available agonist of the prostacyclin (IP) receptor, discovered by Arena and intended for the treatment of PAH, which is a progressive and life-threatening disorder resulting in increased pressure in the arteries carrying blood from the heart to the lungs.
Arena believes an oral non-prostanoid IP agonist, providing similar clinical benefits to presently available IP agonists, can improve the PAH standard of care.