Merck: Phase 3 RECARBRIO RESTORE-IMI 2 trial met primary endpoint
Merck announced that the pivotal Phase 3 RECARBRIO RESTORE-IMI 2 trial met its primary endpoint. The global, multicenter, randomized, non-inferiority trial investigated the efficacy and safety of Merck's antibacterial product RECARBRIO for use in adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Results from the trial showed RECARBRIO met both the primary and key secondary endpoints of statistical non-inferiority compared to piperacillin/tazobactam in Day 28 all-cause mortality and clinical response at early follow up, respectively, in the modified intent-to-treat population. Rates of adverse events observed in the trial were similar in both groups. Merck plans to present the full data from the trial at a scientific congress in 2020.