A very important update on the phase 3 ZENITH trial for Winrevair (sotatercept) in pulmonary arterial hypertension was presented today at the American College of Cardiologists Annual Scientific Session in Boston, USA. The ZENITH trial evaluated Winrevair compared to placebo in adults with PAH, WHO Group 1, functional class III or IV, at high risk of mortality, who were on maximum tolerated background PAH therapy. At a median follow-up of 10.6 months Winrevair reduced the relative risk of major morbidity and mortality events (composite of all-cause death, lung transplant and worsening-related hospitalization of ≥24 hours) by 76% compared to placebo. 17.4% experienced one or more major morbidity and mortality events, compared with 54.7% of patients vs placebo.
Prof. Marc Humbert is quoted in the company press release as saying that “The ZENITH study represents the first pulmonary arterial hypertension clinical trial with a primary endpoint comprised entirely of major outcome measures – all-cause death, lung transplantation and hospitalization. Winrevair had a significant and clinically meaningful impact on the composite of these outcomes, and together with the growing body of evidence from the clinical development program, these data support the practice-changing potential of WINREVAIR for a broad range of patients with pulmonary arterial hypertension.” Prof. Marc Humbert heads the Department of Respiratory and Intensive Care Medicine Hospital Bicêtre (AP-HP), University Paris-Saclay and Inserm Unit 999.
Read more on the company press release at this link
See also our previous article about sotatercept and the ZENITH trial here
