Merck to stop trial evaluating Winrevair early in pulmonary arterial hypertension

"After closely reviewing the robust efficacy data across a broad spectrum of patients evaluated in the WINREVAIR clinical development program, the steering committee has unanimously concluded that the HYPERION study, evaluating WINREVAIR versus placebo on top of background therapy, has lost clinical equipoise and should be stopped early,” said Dr. Vallerie McLaughlin**, Kim A Eagle MD Endowed Professor of Cardiovascular Medicine and Director, Pulmonary Hypertension Program, University of Michigan in Ann Arbor. “PAH is a progressive and debilitating disease with a high incidence of morbidity and mortality, and we look forward to continuing to evaluate these patients and any potential impact to the treatment landscape as a result of these data.”

“Based on the strong, positive interim efficacy data from the ZENITH trial, as well as the totality of available WINREVAIR data, we concluded that it would not be ethical to continue the HYPERION study,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We are grateful to the dedicated community of patients who participated in these studies and are pleased to offer the option of receiving WINREVAIR through the Phase 3 SOTERIA open-label extension study.”

Findings from the HYPERION study will be available later this year and presented at a future medical congress.

WINREVAIR is currently approved in the U.S. and 38 countries based on the results from the Phase 3 STELLAR trial.