Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH

WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy

Merck, known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 HYPERION study evaluating WINREVAIR (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH) functional class (FC) II or III at intermediate or high risk of disease progression. HYPERION met its primary endpoint of time to clinical worsening (TTCW) as measured by a composite endpoint of all-cause death, the need for non-planned PAH-related hospitalization > 24 hours, atrial septostomy, lung transplantation, or PAH deterioration.

“PAH is a progressive and debilitating disease with a poor prognosis that can be difficult to diagnose and treat. Patients often struggle for years to find a treatment plan that helps manage the disease, so it’s critical to provide new options earlier in the treatment journey,” said Dr. Vallerie McLaughlin**, Kim A Eagle MD Endowed Professor of Cardiovascular Medicine and Director, Pulmonary Hypertension Program, University of Michigan in Ann Arbor. “The HYPERION study demonstrated that WINREVAIR on top of background therapy met its primary outcome measure of reduction in the time to clinical worsening events in adults who have been recently diagnosed with PAH. WINREVAIR has brought significant optimism to patients, their families and investigators and we thank all study participants for being part of this important study.”

“To date, the strong clinical profile of WINREVAIR, a first-in-class activin signaling inhibitor, had been primarily established through previous studies in a prevalent patient population comprised of patients that were several years into their treatment journey. These positive results from HYPERION expand on the body of clinical evidence now including recently diagnosed adults, supporting the practice-changing potential of WINREVAIR in a broad spectrum of PAH patients, including those earlier in their treatment journey," said Dr. Joerg Koglin, senior vice president, head of general and specialty medicine, global clinical development, Merck Research Laboratories. “We look forward to presenting these data to the scientific community at a future medical meeting.”

Results from HYPERION will be presented at an upcoming medical meeting later this year and will be submitted to regulatory authorities. WINREVAIR is currently approved in more than 45 countries based on the results from the STELLAR study.