Another Trial of Winrevair Stopped Early Due to Positive Efficacy
The HYPERION study was evaluating Winrevair in recently diagnosed adults with pulmonary arterial hypertension.
Merck has stopped a study of Winrevair (sotatercept-csrk) early because of positive results seen an interim analysis of a separate trial.
Merck officials made the decision to stop the HYPERION study prior to its scheduled completion. The phase 3 HYPERION study evaluating recently diagnosed adults with pulmonary arterial hypertension (PAH) was stopped because an interim analysis of the ZENITH trial and a review of the totality of data from Winrevair the clinical program to date that showed positive efficacy results, Merck officials said in a news release.
Winrevair is currently approved in the United States and 38 countries to treat pulmonary arterial hypertension and to reduce the risk of clinical worsening events. In preclinical models, Winrevai induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics. The FDA approved Winrevair in March 2024, and it has a list price of $14,420 per vial.
Pulmonary arterial hypertension is a rare, progressive and life-threatening disease in which blood vessels in the lungs narrow, causing strain on the heart. About 40,000 people in the United States are living with PAH. The five-year mortality rate is about 43%.
Vallerie McLaughlin, M.D.
“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,” Vallerie McLaughlin, M.D., said in the news release. She is the Kim A Eagle M.D. Endowed Professor of Cardiovascular Medicine and Director, Pulmonary Hypertension Program at the University of Michigan in Ann Arbor.
The phase 3 HYPERION study was evaluating Winrevair compared with placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension. The study enrolled about 300 patients, and the primary composite outcome measure is time to clinical worsening, as measured by first confirmed morbidity or mortality event. Secondary outcome measures include improvement of six-minute walk distance and improvement and maintenance or achievement of N-terminal pro-B-type natriuretic peptide. Company officials said in the release that findings from the HYPERION study will be available later this year and presented at a future medical congress.
Related: Winrevair Advanced PAH Trial Stopped Early Due to ‘Overwhelming’ Efficacy
The ZENITH study was evaluating Winrevair in advance patients when added to maximum tolerated background PAH therapy on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥24 hours. The study enrolled 172 participants. ZENITH was also stopped early because it had shown a statistically significant and clinically meaningful reduction in morbidity and mortality risk compared with placebo.
Participants in the HYPERION trial will have the opportunity to be part of the open-label, long-term extension study, SOTERIA, which is evaluating the long-term safety, tolerability and efficacy of Winrevair when added to background therapy to treat patients with PAH.
