Nicholas Kartsonis, head of clinical research in infectious diseases and vaccines at Merck Research Laboratories, noted that additional treatment options are needed for critically ill patients with respiratory infections.
Merck’s antibacterial drug Recarbrio hit its primary endpoints in a Phase III trial for use in adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
This morning the company announced results from the Phase III RESTORE-IMI 2 show that Recarbrio (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) met both the primary and key secondary endpoints of statistical non-inferiority at day 28 all-cause mortality and clinical response at early follow up, respectively, compared to Pfizer’s Zosyn (piperacillin/tazobactam). The primary and secondary endpoints of the Phase III trial were met in the modified intent-to-treat population, Merck said. 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.
Nicholas Kartsonis, head of clinical research in infectious diseases and vaccines at Merck Research Laboratories, noted that additional treatment options are needed for critically ill patients with respiratory infections. By focusing on the particular patient population in the Phase III RESTORE-IMI 2 trial, Kartsonis said Merck has “generated robust clinical evidence” for the use of Recarbrio in patients with hospital-acquired and ventilator-associated bacterial pneumonia. Kartsonis added that the company plans to share the data with regulatory agencies as the company looks to move forward with the drug.
In July, Recarbrio was approved for use in patients adult patients who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections, including pyelonephritis, caused by a number of Gram-negative microorganisms, including Klebsiella pneumoniae. Recarbrio is made up of imipenem, a penem antibacterial drug; cilastatin sodium, which is a renal dehydropeptidase inhibitor; and relebactam, which is a beta-lactamase inhibitor. Relebactam has received the U.S. Food and Drug Administration’s Qualified Infectious Disease Product designation and Fast Track status for the treatment of hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.
Data from the late-stage Recarbrio trial comes about three months after Merck’s Zerbaxa won approval under Priority Review for treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain bacteria.
Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia are life-threatening hospital-related pulmonary infections that can particularly impact patients who are already dealing with severe underlying medical conditions. There is a high mortality rate associated with these illnesses. A recent report from the Foundation for the National Institutes of Health Biomarkers Consortium noted that ventilated patients with HABP have a 39% higher rate of mortality than those with VABP, 27%. In addition, Pseudomonas aeruginosa is the most common Gram-negative pathogen in HABP/VABP and is becoming increasingly difficult to treat.
