Actelion Ltd. will present the latest data from its pivotal phase III trial to evaluate selexipag (Uptravi) for the treatment of pulmonary arterial hypertension (PAH) at the American College of Cardiology (ACC) Congress, which is taking place on March 15 in San Diego. The company will share key data on the progress of the drug’s development both for the public and at an invitation-only investor relations event.
Professor Vallerie McLaughlin from the University of Michigan Health System Division of Cardiovascular Medicine in Ann Arbor Michigan will be hosting the oral presentation, entitled “Effect of selexipag on morbidity/mortality in pulmonary arterial hypertension: results of the GRIPHON study” at 12:00 pm, while the meeting with investors will take place on the same day at 6:00 pm.
Selexipag is an orally-administered selective IP prostacyclin receptor agonist that was originally discovered and synthesized by Nippon Shinyaku. The drug works by targeting the prostacyclin receptor, which consequently induces vasodilation and inhibits proliferation of vascular smooth muscle cells. Actelion has evaluated the therapy in preclinical studies, which demonstrated its effectiveness in maintaining efficacy and decreasing the risk of developing side effects.
In addition, the Prostacyclin (PGI2) Receptor agonist In Pulmonary arterial HypertensiON (GRIPHON) study, which will be presented at the congress, is a randomized multi center double-blind placebo-controlled trial including patients with pulmonary arterial hypertension at 181 centers in 39 countries across North and Latin America, Europe Asia-Pacific and Africa. The study aimed to evaluate the efficacy and safety of the therapy in the long-term, and completed enrollment of 1156 patients in May 2013.
The study became the largest randomized controlled study conducted with PAH participants, who were treated with either selexipag or placebo twice a day as well as background therapy of endothelia receptor antagonist and/or a phosphodiesterase-5 inhibitor. In addition to evaluating the efficacy and safety of the drug, the main goal of the investigators was to demonstrate how selexipag can extend the time to the first morbidity or mortality event compared to a placebo. The results were announced by the company last June.
Actelion expects selexipag to become an effective treatment for pulmonary arterial hypertension. Last December the biopharmaceutical company submitted the drug for approval to the U.S. Food and Drug Administration (FDA), and they are currently under regulatory review in New Zealand Canada and Switzerland. In addition, Actelion has also filed an application for centralized Marketing Authorization of selexipag with the European Medicines Agency (EMA), and is now waiting for validation.