First Chinese center for global Phase III clinical trail of MRX-4 and Contezolid Tablets has started
Time:2023-04-04 / View:265 times
On April 4, 2023, Shanghai MicuRx Pharmaceuticals Co., Ltd. (stock code: 688373.SH) announced the initiation of the first domestic center for the global Phase III clinical trial of its independently developed antibacterial drug, MRX-4, in sequential combination with orally administered Contezolid tablets for the treatment of diabetic foot infections caused by Gram-positive multidrug-resistant bacteria.
Contezolid tablets and MRX-4 are innovative azole antimicrobial drugs with global intellectual property rights developed by MicuRx Pharmaceuticals. Contezolid tablets was approved by the National Medical Products Administration (NMPA) on June 1, 2021, for the treatment of complicated skin and soft tissue infections, marking the first global approval of this drug. MRX-4, developed based on Contezolid tablets, serves as a prodrug of Contezolid. After the approval of MRX-4 for intravenous administration, clinical physicians can choose to independently use intravenous MRX-4 or sequentially administer contezolid tablets for the treatment of infections caused by drug-resistant Gram-positive bacteria.
The international multi-center Phase III clinical trial studying the sequential administration of MRX-4 and Contezolid tablets for the treatment of diabetic foot infections is a randomized, double-blind study. Its primary objective is to evaluate the safety and efficacy of MRX-4/Contezolid tablets in moderate to severe diabetic foot infections (DFI). The trial design includes a “head-to-head” comparison with Pfizer’s marketed drug, Linezolid, in both intravenous and oral forms. This trial is planned to be conducted in 70 clinical research centers across China, the United States, and major European countries. In May 2022, the trial initiated global Phase III clinical trial enrollment and administered the first patient at Harbor-UCLA Medical Center in Los Angeles. In December 2022, the trial received approval for clinical trial application submissions in European Union countries. As one of the participating countries in this trial, the initiation of the clinical center in China will further facilitate the research progress of this trial.
Notably, this registration clinical trial will be led by Professor Ran Xingwu, Director of the Diabetic Foot Diagnosis and Treatment Center at West China Hospital, Sichuan University. Professor Ran Xingwu is the Associate Director of the Department of Endocrinology at West China Hospital, Sichuan University, as well as the Executive Committee Member of the Chinese Society of Endocrinology and the Head of the Diabetic Foot Disease and Peripheral Arterial Disease Study Group. He has edited or co-authored more than 20 academic monographs, led the development of one Chinese guideline for the prevention and treatment of diabetic foot and three related consensus statements, and participated as a key member in the development of the Chinese guidelines for the diagnosis and treatment of type 2 diabetes. He is highly influential in this field.