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ARTICLE | Clinical News

Arena's ralinepag meets primary in Phase II for PAH

July 13, 2017 11:46 PM UTC

Arena Pharmaceuticals Inc. (NASDAQ:ARNA) reported top-line data from the Phase II APD811-003 trial in 61 patients with pulmonary arterial hypertension (PAH) showing that oral ralinepag (APD811) met the primary endpoint of improving the absolute change from baseline to week 22 in median pulmonary vascular resistance (PVR) vs. placebo (improvement of 163.9 dyn.s.cm-5 vs. a worsening of 0.7 dyn.s.cm-5, p=0.02). Ralinepag non-significantly improved 6-minute walk distance (6MWD) from baseline to week 22 vs. placebo (36.2 vs. 29.4 meters). Ralinepag was titrated over 9 weeks, followed by a 13-week treatment period.

Other endpoints in the double-blind, international trial include the proportion of patients who exhibit clinical worsening and safety...