Shanghai MicuRx Pharmaceutical Co., Ltd. („MicuRx“, 688373.SH) announced the successful completion of its Phase III clinical trial of MRX-4 for injection transitioning to oral Contezolid tablets for the treatment of adult patients with complex skin and soft tissue infections (cSSTI) in China. The trial achieved its primary efficacy endpoint, and the company will actively move forward with the New Drug Application (NDA) process of MRX-4 for injection in China.
This clinical trial was designed to evaluate MRX-4 for injection transitioning to oral Contezolid tablets in comparison to intravenous Linezolid for treating adult patients with cSSTI (including those caused by methicillin-resistant Staphylococcus aureus (MRSA)). The results of the study showed that the intravenous infusion of MRX-4 at 2000 mg for the first dose, followed by 1000 mg (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 showed that MRX-4/Contezolid were non-inferior to the Linezolid group in terms of clinical efficacy, achieving the primary endpoint of the study.
Regarding safety, the study showed that the MRX-4/Contezolid regimen had good safety and tolerability. No adverse events related to the study drug led to treatment discontinuation or withdrawal from the trial. The clinical adverse events related to the study drug were primarily gastrointestinal reactions, including nausea and vomiting. Laboratory abnormalities related to the study drug were elevations in liver enzymes. Most of them were mild and transient. Additionally, the incidence of platelet reduction and hematological adverse events in the MRX-4/Contezolid group was significantly lower than in the Linezolid group.
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