MicuRx Pharmaceuticals actively published R&D data at IDWEEK 2022 to assist in the treatment of multi-drug resistant bacterial infections

Poster Summary

The primary efficacy and safety of MRX-1/MRX-4 are similar across gender and BMI

Subjects with mild and moderate renal impairment achieve comparable primary efficacy and safety to subjects with normal renal function, without dose adjustment for MRX-1/MRX-4

The platelet safety data from the Phase 2 and 3 clinical trials on the MRX-1 treatment of complex skin and soft tissue infections are significantly different from that of linezolid

The ID Week 2022 was held in Washington, D.C., USA, from October 19 to 23, 2022. On October 22, the clinical efficacy and safety data on the high-profile contezolid (CZD/MRX-1) and its prodrug CZA (MRX-4) in four Phase 2 and 3 clinical trials for treatment of skin and soft tissue infections in multiple subpopulations was published through a poster session at the ID Week. The data showed that CZD/CZA had similar clinical efficacy and safety across subpopulations; they showed a hematology-related safety advantage compared with similar drugs.

In a poster titled "Phase 2 and 3 Clinical Trials for the Efficacy and Safety of CZD and CZA in Skin Infection Patients across BMI and Gender", the data from four completed Phase 2 and 3 clinical trials on skin and soft tissue infections showed that CZD/CZA had similar primary efficacy and safety in subjects across gender and BMI, further supporting that no weight and gender distinction is required for subjects enrolled in the ongoing global Phase 3 clinical studies of diabetic foot and acute bacterial skin and soft tissue infections.

For any treatment, the enrollment of special populations is an important clinical concern. In the two posters, the results of CZD/CZA treatment in the subgroup population with impaired renal function were analyzed and interpreted. The analysis of data from four completed Phase 2 and 3 clinical trials on skin and soft tissue infections showed that subjects with mild and moderate renal impairment had comparable primary efficacy and safety to subjects with normal renal function, and for subjects with mild and moderate renal impairment, no dose adjustment of CZD/CZA was required. Further analysis of pharmacokinetic data from Phase 3 clinical trials for CZD treatment of complicated skin and soft tissue infections showed similar results in subjects with mild to moderate renal impairment and subjects with normal renal function.

This finding also supports the enrollment of subjects with impaired renal function for the ongoing global Phase 3 clinical study of diabetic foot and acute bacterial skin and soft tissue infections. For them, no dose adjustment is required.

In addition, in a poster, it was reported the results of platelet safety data from two Phase 2 and 3 clinical trials of CZD treatment in complicated skin and soft tissue infections. Mean platelet counts did not decrease in subjects with CZDs but decreased significantly in subjects with linezolid over 7 to 14 days of treatment. Further analysis of data from subjects in the subpopulation treated for ≥ 11 days showed more pronounced differences in mean platelet counts. Hematologic safety will also be the focus of global Phase 3 clinical studies.

Rapid advancement and excellent clinical data not only highlight the advantages of MicuRx Pharmaceuticals on safety and efficacy, but also herald the possibility of more drug approvals in the future.

As a new "super antibiotic" with global originality, independent property rights and international research and development, contezolid was approved for marketing in China in June 2021 and entered the catalog of medicines covered by national medical insurance system of China in the same year, which was officially implemented under the catalogue on January 1, 2022. The global multi-center clinical trials meet international regulatory regulations, and the product has the potential to enter the Chinese, US, EU and global markets in the future to provide more optimized treatment options and stronger relief for more patients infected with multi-drug resistant bacteria.

About CZD

Contezolid (CZD/MRX-1) is the first category 1 innovative drug marketed in China and belongs to a new generation of oxazolidinone antibacterial drugs. Currently its approved indications in China are complicated skin and soft tissue infections. Its antibacterial spectrum can cover positive cocci, positive bacilli, mycobacteria and fungoids, especially with high antibacterial activity against resistant strains. Because of its particularity in mechanism of action and structure, the cross-resistance to drugs of contezolid with other types of antibacterial drugs is not easy to occur, and its drug resistance is more difficult to arise than that of similar drugs. Both contezolid and linezolid are small molecule drugs of the same oxazolidinone class, and their oral preparations can be rapidly distributed into the subcutaneous tissue after administration and absorption. Meanwhile, they have strong penetration into other tissues and are widely distributed in the body. Current clinical studies have demonstrated that the clinical efficacy of contezolid is comparable to that of linezolid, but its risk of hematological toxicity and drug-drug interactions is significantly reduced.

About CZA

CZA (MRX-4) is a water-soluble prodrug, uniquely designed and developed based on the structure of contezolid. It has a novel molecular structure and can be converted to contezolid for efficacy in vivo. On the basis of the oral administration, the way of intravenous administration of CZA (MRX-4) is added to provide more medication options for different clinical application scenarios. The global multicenter Phase 3 clinical studies of CZA (MRX-4) in treatment of the diabetic foot and skin and soft tissue acute bacterial infections are currently being rolled out.

About MicuRx Pharmaceuticals

MicuRx is a biopharmaceutical company focusing on novel therapeutics for infectious diseases. With global independent intellectual property and competitiveness, we are committed to the discovery, development, and commercialization of innovative drugs for unmet medical needs. Since the company was founded in 2007, MicuRx has adhered to the principle of “Better therapy through superior medicine", focusing on the increasingly serious problem of global antimicrobial resistance. With the core competitiveness of solving clinical problems and differentiated innovation, our goal is to provide more effective and safer therapeutic options for patients suffering the most common and serious drug-resistant bacterial infections.