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.

Clinical Trial Results and Key Findings

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.

Impact of the Study and Future Plans

The success of this clinical trial is expected to enable MRX-4 for injection to be approved and commercialized in China for the first time. After being launched, it can provide more medication convenience for critically ill patients and patients who are not suitable for oral administration, meeting clinical needs and significantly boosting the company's revenue from the Chinese market. This success lays a solid foundation for the drug's future commercialization, and the company will continue to invest in this project, with plans to complete communications with the CDE, submit the NDA, and undergo technical reviews and site inspections.

Additionally, based on the company's lifecycle management plan for oral Contezolid tablets and MRX-4 for injection, MicuRx is planning to conduct a Phase III clinical trial in China for MRX-4/Contezolid tablets in the treatment of infections caused by drug-resistant Gram-positive bacteria at various sites. This trial aims to expand the potential indications and enhance the social and commercial value of the drug. Furthermore, the international multicenter Phase III clinical trial for MRX-4/Contezolid tablets in the treatment of diabetic foot infections will continue, with China being one of the participating countries.