SAN DIEGO, Dec. 10, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today the initiation of dosing in a Phase 1 clinical trial of APD811, a novel oral drug candidate discovered by Arena that targets the prostacyclin receptor for the treatment of pulmonary arterial hypertension, or PAH.
"An orally bioavailable prostacyclin receptor agonist could improve the standard of care for patients with PAH, a life-threatening disorder," said William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer. "APD811 is a non-prostanoid compound; in preclinical studies, the oral uptake, half life and efficacy characteristics suggest that it could offer improved administration over current prostacyclin receptor therapies."
This randomized, double-blind and placebo-controlled Phase 1 trial is planned to enroll up to 72 healthy adult volunteers and will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses of APD811.
"While our primary focus is on achieving FDA approval of lorcaserin for weight management, we see value in advancing our promising earlier-stage compounds that may also address underserved medical needs," said Jack Lief, Arena's President and Chief Executive Officer. "With a measured investment, we aim to establish a favorable pharmacokinetic and preliminary safety profile for APD811 in this trial."
AboutPulmonary Arterial Hypertension (PAH)
PAH is a progressive, life-threatening disorder characterized by increased pressure in the arteries that carry blood from the heart to the lungs. The increased pressure puts a strain on the heart, which can lead to limited physical activity and a reduced life expectancy. Over time, the heart muscle weakens and can no longer pump blood efficiently. If PAH is not treated, the heart will eventually fail. Data from the National Institutes of Health Registry indicate that without treatment, patients in the United States with PAH have a median survival time of approximately three years from diagnosis.
APD811, a potent and selective agonist (or activator) of the prostacyclin receptor, is Arena's internally discovered drug candidate for the treatment of PAH. Prostacyclin receptor agonists, through regulation of vascular smooth muscle tone, improve mortality and exercise tolerance in PAH patients and are among the treatments administered as standard of care for advanced PAH. Currently available prostacyclin receptor agonists belong to the prostanoid class of molecules and these products need to be administered frequently or continuously through intravenous, subcutaneous or inhaled routes. Arena believes that APD811, as a non-prostanoid prostacyclin agonist, has the potential to improve the standard of care for PAH by providing an oral form of administration with clinical benefits similar to currently available prostacyclin receptor agonists.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is intended for weight management. Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States following FDA approval of the New Drug Application for lorcaserin.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company.