Arena completes enrollment in trial for oral pulmonary arterial hypertension drug
Arena Pharmaceuticals announced that it had completed enrollment in a phase 2 trial evaluating ralinepag, an oral medication for pulmonary arterial hypertension.
The FDA has not approved ralinepag, but it granted the medication an orphan drug designation for pulmonary arterial hypertension in September 2014. An orphan drug designation is intended for medications that treat diseases or conditions affecting fewer than 200,000 individuals in the U.S.
The phase 2 trial has enrolled approximately 60 patients with pulmonary arterial hypertension, which Arena said has an estimated five-year survival rate of 57 percent.
The company mentioned that the randomized, double-blind, placebo-controlled study is evaluating the effectiveness of ralinepage in reducing pulmonary vascular resistance and improving exercise capacity as well as testing its tolerability and safety.
The primary outcomes are the change from baseline in pulmonary vascular resistance and the change from baseline in six-minute walk distance.