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."
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