MicuRx Announces the Enrollment of First Patient in Global Phase III Trial for Treatment of Diabetic Foot Infection
Time:2022-05-02 / View:1,931 times
Shanghai, China, and Foster City, US – May 1, 2022 – Shanghai MicuRx Pharmaceutical Co., Ltd. (MicuRx), a leading biopharmaceutical company focusing on novel therapeutics for infectious diseases, today announced that the first patient has been enrolled into a diabetic foot infection (DFI) clinical trial with Contezolid Acefosamil (MRX-4) for injection followed by Contezolid tablet at the Harbor-UCLA Medical Center located in Los Angeles.
This will be one of the worldwide registration clinical trials for a New Drug Application (NDA) of Contezolid Acefosamil for injection, and will also support the indication expansion of Contezolid tablet.
Dr. Zhengyu Yuan, founder and CEO of MicuRx, commented, “This is the first multiregional clinical trial for MicuRx, and it is a key milestone for the globalization of the MicuRx pipeline which will also helps to bring these two innovative drugs to patients globally”.
This trial is a phase III, multicenter, randomized, double-blinded study to evaluate the safety and efficacy of Contezolid Acefosamil and Contezolid compared to Linezolid administered intravenously and orally in patients with moderate or severe diabetic foot infections.
Dr. Edward Fang, Chief Medical Officer of MicuRx further commented, “The phase III DFI study comparing Contezolid Acefosamil/Contezolid to Linezolid will be carried out in more than 70 clinical sites in the US, China, and European countries. The results of the study will be used to support a New Drug Application (NDA) for Contezolid Acefosamil and Contezolid in major markets around the world.”
About Contezolid Tablet and Contezolid Acefosamil for Injection
Contezolid and Contezolid Acefosamil are new generation oxazolidinone antibacterial drugs, which were discovered and are being developed by MicuRx. Contezolid tablet has been approved in June, 2021, in China for the treatment of complicated skin and soft tissue infections. Data from completed clinical trials and preclinical studies have demonstrated that Contezolid has excellent antibacterial efficacy, no tendency to induce myelosuppression was observed in clinical trials, and decreased potential interactions with inhibitors or inducers of CYP450 enzymes due to its unique metabolism by flavin monooxygenase 5 (FMO5).
Contezolid Acefosamil is a water-soluble prodrug design based on the structure of Contezolid, which exerts its therapeutic effect by converting into Contezolid in the human body. A phase II clinical trial for acute bacterial skin and skin structure infections has been completed in the United States. Contezolid Acefosamil for injection can provide a new choice for physicians and patients.
Both Contezolid and Contezolid Acefosamil have received Qualified Infectious Disease Product (QIDP) certification from the US Food and Drug Administration (FDA), which grants both drugs Fast Track designation and additional market exclusivity after approval in the US.
About Diabetic Foot Infections
Diabetic foot infection (DFI) is the most common diabetic complication requiring hospitalization, involving the skin, soft tissue, and/or bone (with or without a diabetic foot ulcer), which is the most common cause of lower extremity amputation. In most countries, Gram-positive aerobic cocci are the main cause of acute DFI. Among these pathogens, Staphylococcus aureus is the most frequently isolated pathogen. The prevalence of drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) is increasing. Moderate and severe DFI require up to 4 weeks of antimicrobial drug therapy. Currently, there are only 3 antibacterial drugs approved by the US FDA for DFI indications: Linezolid, Ertapenem, and Piperacillin/Tazobactam. Despite these available treatments, DFI patients have suboptimal rates of resolution. It has been reported that the cure rate may only be approximately 50%, mortality rate reaches 15%, and relapse occurs for 15-30% of patients within 1 year1.
With global independent intellectual property rights and international competitiveness, MicuRx is focusing on novel therapeutics for infectious diseases. The Company is committed to the discovery, development, and commercialization of innovative drugs for unmet medical needs. Since its inception, the company has adhered to the concept of “Better Therapy through Superior Medicine”, focusing on the increasingly serious problem of bacterial drug resistance in the world and offering more effective and safer treatment options for the most common and serious drug-resistant bacterial infections.
1. Lipsky BA, Senneville E, Abbas Z, et al. IWGDF Guideline on the diagnosis and treatment of foot infection in persons with diabetes. IWGDF, 2019.