US-based pharmaceutical giant Merck & Co., Inc. (NYSE: MRK) has announced positive interim analysis results from the pivotal Phase III ZENITH study for its activin signaling inhibitor, Winrevair (sotatercept-csrk). The study focused on the efficacy and safety of sotatercept in treating adults with pulmonary arterial hypertension (PAH) who are in functional class (FC) III or IV and at a high risk of mortality.
Achievement of Primary Endpoint in ZENITH Study
The ZENITH study successfully met its primary endpoint, showing that sotatercept significantly reduced the risk of morbidity or mortality events in patients with PAH compared to placebo. These events include all-cause death, lung transplantation, or hospitalization due to PAH worsening for 24 hours or more. The significant reduction in risk, as demonstrated by the study, has led to a recommendation from an independent data monitoring committee to stop the ZENITH study ahead of schedule due to the strong data.
Sotatercept’s First-in-Class Activin A Receptor IIA Inhibitor Status
Sotatercept is a first-in-class activin A receptor IIA inhibitor that has been approved in the US and 36 other countries, supported by the positive results from the Phase III STELLAR study. This approval underscores the potential of sotatercept as a treatment for PAH and its importance in improving patient outcomes in this critical therapeutic area.-Fineline Info & Tech
