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Ralinepag may improve pulmonary vascular resistance in patients with PAH
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Arena Pharmaceuticals announced that phase 2 results from a study of ralinepag showed an absolute change in pulmonary vascular resistance in patients with pulmonary artery hypertension.
“PAH is a complex and serious disease, often with a poor prognosis despite the use of currently available treatments,” Vallerie V. McLaughlin, MD, Kim A. Eagle MD Endowed Professor of Cardiovascular Medicine and the director of the Pulmonary Hypertension Program at the University of Michigan in Ann Arbor, said in a press release. “New therapeutic options to manage patients with PAH are needed. The results of this phase 2 study of ralinepag, in patients already receiving, in most cases, multiple background therapies, showed a clinically meaningful improvement in [pulmonary vascular resistance], a well-established indicator of treatment benefit, believed to be correlated with long-term clinical outcomes in patients with PAH.”
Researchers assigned 61 patients with PAH either ralinepag, a prostacyclin receptor antagonist in development, or placebo. Treatment was titrated for 9 weeks with a 13-week treatment period afterwards.
The primary efficacy endpoint was an absolute change in pulmonary vascular resistance from baseline at 22 weeks. Other endpoints were clinical worsening, improvement in 6-minute walk test, tolerability and safety.
Median pulmonary vascular resistance improved in patients assigned ralinepag by 163.9 dyn.s.cm-5 vs. a 0.7 dyn.s.cm-5 decline in the placebo group (P = .02), according to the release, which also stated a 29.8% improvement in pulmonary vascular resistance was seen in the ralinepag group vs. placebo (P = .03). Pulmonary vascular resistance improved by 20.1% compared with baseline in patients assigned ralinepag.
Adverse events in patients assigned ralinepag were similar to other prostacyclin treatments.
Full study results will be presented at future medical meetings, according to the release. – by Darlene Dobkowski
Disclosure: McLaughlin reports serving as a consultant and/or advisor for Actelion Pharmaceuticals, Arena Pharmaceuticals, Bayer, Gilead Sciences, Steadymed, St. Jude Medical and United Therapeutics.