Merck announces data from Phase 2 Cadence trial of Winrevair

Merck (MRK), known as MSD outside of the United States and Canada, announced detailed results from the Phase 2 Cadence study, which was designed to evaluate the efficacy, safety and tolerability of two doses of Winrevair for the treatment of adults with the syndrome of combined post- and precapillary pulmonary hypertension and heart failure with preserved ejection fraction. In this distinct patient population, Winrevair showed a statistically significant and clinically meaningful reduction from baseline in pulmonary vascular resistance, PVR, versus placebo at week 24, with a 1.02 Wood units reduction for the 0.3 mg/kg dose and a 0.75 Wood units reduction for the 0.7 mg/kg dose. As noted below, important secondary endpoints explored include six-minute walk distance, echocardiographic measures, N-terminal pro-B-type natriuretic peptide levels and time to clinical worsening, TTCW. In this Phase 2 study designed to assess proof-of-concept and different doses, patients in the Winrevair 0.7 mg/kg arm showed an increase of 5.8 meters in 6MWD that did not reach statistical significance. While subsequent secondary endpoints were not formally tested due to the prespecified hierarchical testing strategy, there was a 20.3-meter increase from baseline in 6MWD in patients treated with Winrevair 0.3 mg/kg