Shanghai MicuRx Pharmaceutical Co., Ltd. (SHA: 688373) has announced that its Phase III study for MRX-4, transitioning to oral contezolid tablets for the treatment of adult patients with complex skin and soft tissue infections (cSSTI), has successfully met its primary efficacy endpoint.
Phase III Study Design and Results
The multi-center, randomized, double-blind double dummy Phase III study evaluated the safety and efficacy of MRX-4 transitioning to contezolid versus intravenous linezolid in cSSTI. The results indicated that the intravenous infusion of MRX-4 at 2000 mg for the first dose, followed by 1000 mg (with subsequent oral administration of 800 mg Contezolid tablets, referred to as “MRX-4/Contezolid”), administered every 12 hours for a duration of 7-14 days, demonstrated good clinical and microbiological efficacy. Statistical analysis confirmed that MRX-4/Contezolid were non-inferior to the linezolid group in terms of clinical efficacy, achieving the primary endpoint of the study. In terms of safety, the study showed that the MRX-4/Contezolid regimen had good safety and tolerability, with no adverse events related to the study drug leading to treatment discontinuation or withdrawal from the trial.
Contezolid and MRX-4 Background
Contezolid was approved in China in June 2021 for the treatment of complex skin and soft tissue infections. MRX-4, the pro-drug version of contezolid (MRX-1), is a potent oxazolidinone antibiotic against Gram-positive pathogens. The MRX-4/contezolid combination has been previously approved for use as a sequential treatment for infections caused by drug-resistant Gram-positive bacteria in multiple countries, as well as for diabetic foot infection.
Plans for New Drug Application (NDA)
With the positive Phase III data, MicuRx plans to complete communications with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and submit a New Drug Application (NDA) for the MRX-4/Contezolid combination.-Fineline Info & Tech
