Long-Term Selexipag Phase 3 Clinical Trial Results For PAH Recently Presented

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by Maureen Newman |

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Long-term results for the GRIPHON trial are in. According to a presentation made at the 35th Annual International Society for Heart and Lung Transplantation (ISHLT) Meeting & Scientific Sessions, selexipag (otherwise known as Uptravi® from Actelion) effectively treats patients with pulmonary arterial hypertension. Patients saw an enhanced outcome of disease when treated with selexipag rather than placebo and had a 40% lower risk for morbidity and mortality events than patients receiving placebo treatment.

“The GRIPHON study is indeed a groundbreaking step forward in pulmonary hypertension,” said Andreas Zuckermann, MD, ISHLT 2015 Scientific Program Committee Chair, in a news release from ISHLT. “ISHLT has a profound interest in these results as pulmonary hypertension is one of the key areas the society is concentrating on in the future.”

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Over 1,100 patients with pulmonary arterial hypertension were treated in the GRIPHON trial. The Phase 3 trial was multicenter, double-blind, and placebo-controlled. An even number of patients received selexipag or placebo, and dosing was titrated based on maximum tolerated dose and perceived benefits of treatment. Everyone was monitored for adverse effects, signs of morbidity and mortality, and time to first morbidity and mortality event.

When the researchers tabulated the results, they found a 40% lower risk for morbidity and mortality events with selexipag treatment. Adverse events were minimal and described further in the presentation, “Effect of Selexipag on Morbidity/Mortality in Pulmonary Arterial Hypertension: Results of the GRIPHON Study.” “Selexipag demonstrated a significant effect on the time to first morbidity/mortality event in pulmonary arterial hypertension patients and had an acceptable safety profile,” stated Dr. N. Galiè, presenting author of the work. “Results from GRIPHON indicate selexipag is an efficacious pulmonary arterial hypertension treatment.”

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As an orally available, selective prostanoid, selexipag is a novel therapeutic agent to treat pulmonary arterial hypertension. Currently, there are a variety of drugs that target different signaling pathways implicated in pulmonary arterial hypertension. These drugs have enabled an increase in exercise tolerance for patients living in the last ten years. The three main pathways targeted by drugs are endothelin receptor are affected by the three main classes of pulmonary arterial hypertension medications: endothelin receptor antagonists, prostacyclin analogs, and phophodiesterase-5-inhibitors. Although selexipag is targeted against the prostacyclin pathway, the chemical makeup of the molecule makes it unique from other prostanoids.