Merck 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, WHO* Group 1) 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.
In HYPERION, WINREVAIR added on top of background therapy (72.2% of patients on double therapy) within 12 months after initial diagnosis of PAH demonstrated a statistically significant and clinically meaningful reduction in the risk of clinical worsening events when compared to placebo. HYPERION is the third Phase 3 study of WINREVAIR to demonstrate significant efficacy in adults with PAH. The first was the STELLAR study previously presented at ACC.23, followed by the ZENITH study presented at ACC.25. In contrast to HYPERION, these previous studies included a patient population where a majority of participants were on triple therapy. The safety profile of WINREVAIR was generally consistent with that observed in previous studies.
As announced in January, HYPERION was stopped early and moved to final analysis based on the positive results from the interim analysis of the Phase 3 ZENITH trial and a review of the totality of data from the WINREVAIR clinical program to date, and all patients were offered the opportunity to receive WINREVAIR through the SOTERIA open-label extension study.
“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.”
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