Merck reports ‘positive’ results from Phase 3 ZENITH trial evaluating Winrevair

Merck (MRK) announced positive topline results from the Phase 3 ZENITH study evaluating Winrevair in adults with pulmonary arterial hypertension functional class III or IV at high risk of mortality. ZENITH met its primary endpoint of time to first morbidity or mortality event. In the study, Winrevair demonstrated a statistically significant and clinically meaningful reduction in the risk of morbidity or mortality events compared to placebo, both on top of background PAH therapy. Based on the strength of these results, an independent data monitoring committee has recommended ZENITH be stopped early and all participants be offered the opportunity to receive Winrevair through the SOTERIA open-label extension study. In preliminary assessment, adverse events and serious adverse events were balanced between the treatment groups.