Phase III Winrevair trial meets endpoint, says Merck

Positive top-line results from the Phase III ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) III or IV at high risk of mortality, were released today by US pharma giant Merck & Co (NYSE: MRK).

The ZENITH study met its primary endpoint of time to first morbidity or mortality event (all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours). 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.

Merck noted that, 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.