Merck presents new analyses from Sotatercept studies for adults with pulmonary arterial hypertension
Rahway: Merck, known as MSD outside of the United States and Canada, has announced new analyses from studies of sotatercept, Merck’s novel investigational activin signaling inhibitor biologic, for adults with pulmonary arterial hypertension (PAH) (WHO Group 1) at the European Respiratory Society (ERS) International Congress 2023. A new exploratory post-hoc analysis of right heart catheterization and echocardiography data from patients in the Phase 3 STELLAR study showed treatment with sotatercept for 24 weeks on top of background therapy reduced right heart size and improved right-ventricular (RV) function and hemodynamic status. This analysis was featured in an oral presentation, with simultaneous publication in the European Respiratory Journal. An interim analysis of the Phase 3 SOTERIA open-label extension study was also presented, representing the longest safety and efficacy analysis of sotatercept to date.
“There is an urgent need for new approaches to manage PAH, a rare, progressive, and ultimately life-threatening disease,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These latest data build on the clinically meaningful efficacy results from the STELLAR trial and support our belief that sotatercept has the potential to transform the treatment of PAH. PAH can strain the heart and lead to eventual right heart failure, so we are particularly encouraged by the exploratory analysis from STELLAR suggesting that treatment with sotatercept improved right heart size and function.”
Primary efficacy results from STELLAR, in which sotatercept on top of background therapy demonstrated a statistically significant and clinically meaningful improvement in 6-minute walk distance (6MWD) at 24 weeks and eight of nine secondary outcome measures, were presented at ACC.23/WCC and published in The New England Journal of Medicine. Merck submitted an application for regulatory approval of sotatercept to the U.S. Food and Drug Administration and plans to submit applications to additional regulatory agencies worldwide.
At ERS 2023, nine Merck-sponsored studies in PAH were presented. These include an oral presentation of a population health model predicting the long-term impact of sotatercept on morbidity and mortality in patients with PAH (#OA740).
