MicuRx Pharmaceutical: Contezolid Global Phase III Clinical Trial Safety and Efficacy Evaluation Endorsed by Data Monitoring Committee, Promising Prospects for Diabetic Foot Infection Treatment

• Data Monitoring Committee (DMC) has completed the first safety and efficacy assessment of the global Phase III clinical trial, recommending continued progression as planned 
• MRX-4 Injection followed by Contezolid Tablets demonstrated favorable safety and efficacy profiles in patients with diabetic foot infections (DFI), meeting expectations 

SHANGHAI, Feb. 25, 2025 /PRNewswire/ -- Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", 688373.SH) announced significant progress in its global multicenter Phase III clinical trial evaluating MRX-4 Injection followed by Contezolid Tablets for the treatment of DFI. The DMC has completed its first safety and efficacy assessment, confirming that the drug's safety and efficacy profiles meet favorable expectations and recommending the trial proceed as planned. 

DMC Endorsement: Safety and Efficacy Meet Favorable Expectations

This evaluation was conducted in accordance with the DMC charter, analyzing the safety and efficacy data of the first 33% of enrolled subjects (285 cases) who completed the study. The results showed that MRX-4 Injection followed by Contezolid Tablets demonstrated favorable safety and efficacy profiles in treating moderate-to-severe DFI patients, meeting expectations. Based on this, the DMC unanimously recommended no adjustments to the trial, injecting confidence into subsequent clinical advancement. 

Addressing Unmet Needs and Targeting Global Markets 

DFI is one of the severe complications of diabetes. In China, the number of DFI patients was 4.76 million in 2018, growing to 5.2 million by 2024 at a compound annual growth rate (CAGR) of 1.5%. It is projected to reach 5.36 million by 2030 and 5.42 million by 2035. In the United States, 3.65 million patients suffered from DFI in 2018, increasing to 3.76 million by 2024 at a CAGR of 0.5%. The number is expected to rise to 3.84 million by 2030 and 3.89 million by 2035.

Antibiotic therapy is the cornerstone of DFI treatment. MRX-4 Injection and Contezolid Tablets, as a new generation of oxazolidinone antibiotics, reduce risks such as myelosuppression—common with traditional therapies—through structural optimization, making them particularly suitable for patients requiring long-term treatment. Contezolid Tablets, approved in China in 2021 for complicated skin and soft tissue infections (cSSTI), have already demonstrated robust clinical safety. MRX-4, a water-soluble prodrug of Contezolid, converts into Contezolid in vivo to exert therapeutic effects. In 2023, both Contezolid Tablets and MRX-4 received U.S. FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for treating moderate-to-severe DFI without concurrent osteomyelitis. 

This global Phase III trial is an international multicenter, randomized, double-blind, controlled study comparing MRX-4 Injection followed by Contezolid Tablets with linezolid in treating moderate-to-severe DFI patients. The trial plans to enroll 865 patients, with a treatment duration of 14 to 28 days. 

Mr. Jerry Li, CFO and President of MicuRx U.S., stated, "The DMC's positive evaluation underscores the promising efficacy and safety of MRX-4 Injection and Contezolid Tablets, marking a critical milestone toward global market entry. We anticipate this therapy will offer DFI patients a safer treatment option while addressing antibiotic resistance challenges." 

Dr. Zhengyu Yuan, Chairman and CEO of MicuRx, emphasized, "The development of MRX-4 and Contezolid has always focused on unmet clinical needs. DFI patients urgently require better-tolerated innovative therapies suitable for long-term use, and the current data further validate their potential." 

Forward-Looking Statements

This press release contains certain forward-looking statements. These statements are not historical facts but are based on the Company's current predictions or expectations regarding future events based on available data and information. Words such as "anticipate," "believe," "continue," "may," "estimate," "expect," "intend," "plan," "potential," "predict," "project," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, though not all such statements include these specific terms. These forward-looking statements involve known and unknown uncertainties and other significant factors that may cause actual results to differ materially from those expressed or implied due to risks associated with policy, R&D, market conditions, regulatory uncertainties, and other variables. Existing and potential investors are cautioned to carefully evaluate these risks and not to rely unduly on the forward-looking statements herein. 

Any forward-looking statements contained in this press release are made only as of the date of this press release. Unless required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events, or circumstances. 

SOURCE MicuRx Pharmaceuticals