The clinical results of phase 3 of the treatment of pneumonia with a new combination of antibiotics in Mercedon came out

May 6 U.S. time, Mercator announced detailed results of a Phase 3 clinical trial (RESTORE-IMI 2) evaluating the efficacy and safety of its new antibiotic combination Recarbrio for adult patients with hospital-acquired/ventilator-related bacterial pneumonia (HABP/VABP). The results showed that Recarbrio showed statistically non-poor statistical effectiveness in terms of all-cause mortality and clinical response on the 28th day compared to pyracillin/tazobactam (PIP/TAZ) in terms of the main endpoints and secondary endpoints of the study. The results are consistent with a summary published at the 30th European Conference on Clinical Microbiology and Infectious Diseases (ECCMID).RESTORE-IMI 2 is a global, randomized, double-blind, non-inefficient Phase 3 clinical trial. A total of 537 patients participated in the study and were randomly assigned to Recarbrio (imipenem 500mg / cilastatin 500mg / relebactam 250mg) or PIP/TAZ (4000mg / tambatan 500mg) for 7 to 14 days every 6 hours. Patients in both groups were also given open-label linazine (600mg) until baseline culture no longer detected methicillin-resistant Staphylococcus aureus (MRSA). The main endpoint indicator was total cause mortality on the 28th day, and the key secondary endpoint was the clinical response of early follow-up (7 to 14 days after completion of treatment).The results showed that Recarbrio reached the main and secondary end points of the study. The data were 15.9 per cent (42/264) for patients in the Recarbrio treatment group and 21.3 per cent (57/267) for the PIP/TAZ treatment group (the difference in adjusted treatment was 5.3 per cent and 95 per cent confidence interval .CI: -11.9, 1.2). The clinical response to early follow-up was good in patients in the Recarbrio treatment group, at 60.9% (161/264) and in the PIP/TAZ group at 55.8% (149/267) (adjusted treatment difference was 5%, 95% CI:-3.2, 13.2).The overall adverse event (AE) rates were similar in both treatment groups, with 84.9 per cent in the Recarbrio group and 86.6 per cent in the PIP/TAZ group. In addition, the treatment interruption rate was similar for both groups due to any AE, with 6% in the Recarbrio group and 8% in the PIP/TAZ group. The rate of discontinuation of treatment caused by drug-related AE was similar, with 2.3 per cent in the Recarbrio group and 1.5 per cent in the PIP/TAZ group.Recarbrio is a fixed-dose combination of antibiotics consisting of relebactam, imipenem and cilastatin, relebactam is an innovative β-endamidease inhibitor, imipenem is a approved β-endamide antibiotic, and cilastatin prevents imipenem from being broken down by the kidneys.In July 2019, Recarbrio was approved by the FDA for the treatment of adult patients with complex urinary tract infections (cUTI) when treatment options are limited or no alternative, including the treatment of pyelonephritis and complex intraceliac infections (cIAI) caused by susceptible Gloria negative bacteria. In February 2020, the FDA accepted Recarbrio's Application for Complementary New Drugs (sNDA) for HAP/VABP Adult Patients and granted priority review, with a final decision scheduled by June 4, 2020.
(Sina Pharmaceutical News)