Two phase III trials starting with MK 7655 and imipenem/cilastatin for bacterial infections after positive phase II data- Merck Inc

Merck Inc announced that a phase II study of MK 7655 (relebactam), in combination with imipenem and cilastatin, in complicated intra-abdominal infections, met its primary endpoint, and that Merck Inc is now initiating pivotal Phase III studies. In the phase II study, the combination demonstrated noninferiority in the percentage of microbiologically evaluable patients with favorable clinical response at the end of intravenous therapy compared to imipenem/cilastatin alone.

Merck is planning to initiate two pivotal phase III clinical studies of the drugs as a fixed-dose combination. One will compare imipenem/cilastatin/relebactam to colistimethate sodium in combination with imipenem/cilastatin for the treatment of imipenem-resistant bacterial infections. Infections evaluated in this study are hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections. (www.ClinicalTrials.gov Identifier: NCT02452047). A second phase III study will compare treatment with the fixed-dose combination of imipenem/cilastatin/relebactam to piperacillin/tazobactam in patients with hospital-acquired and ventilator-associated bacterial pneumonia. (www.ClinicalTrials.gov Identifier: NCT02493764).