US-based pharmaceutical giant Merck & Co., Inc. (NYSE: MRK) has announced favorable interim analysis results from the pivotal Phase III ZENITH study for its drug Winrevair (sotatercept-csrk), an activin signaling inhibitor. The study’s success marks a significant milestone in the treatment of pulmonary arterial hypertension (PAH).
ZENITH Study Design and Primary Endpoint Achievement
The ZENITH study aimed to evaluate the efficacy of sotatercept in adults with PAH who are in functional class (FC) III or IV and are at a high risk of mortality. The study successfully met its primary endpoint, showing a statistically significant and clinically meaningful reduction in the risk of morbidity or mortality events. These events include all-cause death, lung transplantation, or PAH worsening related hospitalization of 24 hours or more, compared to placebo.
Recommendation to Stop the Study Early
The robust data from the study has led to a recommendation by an independent data monitoring committee to stop the ZENITH study early. This recommendation is a testament to the potential impact of sotatercept in improving outcomes for PAH patients.
Sotatercept’s First-in-Class Activin A Receptor IIA Inhibitor Status
Sotatercept, a first-in-class activin A receptor IIA inhibitor, has already been approved in the US and 36 other countries, supported by the positive results from the Phase III STELLAR study. The drug’s mechanism of action targets the activin A signaling pathway, which plays a crucial role in the pathogenesis of PAH.-Fineline Info & Tech
