Contezolid Acefosamil

SHANGHAI, Nov. 29, 2024 /PRNewswire/ -- Recently, 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. About Contezolid Tablets and MRX-4 Contezolid tablets and MRX-4 are novel oxazolidinone-class antibacterial drugs developed by MicuRx, with global intellectual property rights. Contezolid tablets (400 mg) were approved by the NMPA in China on June 1, 2021, for the treatment of cSSTI, marking the first approval worldwide. MRX-4 for injection is a water-soluble prodrug of contezolid, developed by the company based on an in-depth analysis and scientific investigation of contezolid. MRX-4 for injection can be converted into the active ingredient contezolid in the human body, expanding the usage scenarios. SOURCE MicuRx Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

FOSTER CITY, Calif., Sept. 22, 2023 /PRNewswire/ -- MicuRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and the Fast Track Designation under the Generating Antibiotic Incentives Now (GAIN) Act for contezolid (MRX-I) tablet and contezolid acefosamil (MRX-4) tablet and intravenous as novel new oxazolidinone antibiotics for the treatment of moderate to severe diabetic foot infection (DFI) without concomitant osteomyelitis. Oral contezolid and intravenous (IV) contezolid acefosamil are currently being studied in a global Phase 3 clinical trial in treatment of patients with DFI. QIDP designation provides both products with a five-year extension of data exclusivity provisions and eligibility for Priority Review of its New Drug Application (NDA) for DFI once submitted. Both products were previously granted QIDP designation and Fast Track status in 2018 for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Continue Reading MicuRx Pharmaceuticals The QIDP and Fast Track designations were created as part of the Food and Drug Administration Safety and Innovation Act, FDASIA (June 2012), Title VIII – Generating Antibiotic Incentives Now (GAIN) Act, to encourage development of treatments for antibiotic-resistant organisms known to cause serious or life-threatening infections. "We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection", stated Dr Zhengyu Yuan, Chief Executive Officer at MicuRx. Approximately 18.6 million people worldwide are affected by a diabetic foot ulcer each year, including 1.6 million people in the United States. About half of ulcers become infected and can lead to significant morbidity and mortality. When under- or untreated, severe DFI infections can progress to osteomyelitis (infection of the bone), significant tissue and bone damage, and result in amputation of the infected limb in 17% of cases of diabetic ulcers.[1] Prevalence of DFI is increasing as the prevalence of diabetes increases worldwide. With excellent microbiological activity against common Gram-positive bacteria, contezolid and contezolid acefosamil are well positioned to benefit DFI patients, particularly due to methicillin-resistant Staphylococcus aureus (MRSA). Staphylococcus sp. are the most common bacteria causing DFI, and the rate of methicillin resistance in S. aureus remains at high levels ranging from 25-65% with wide regional variation in the USA. Given the difficulty and significance of diabetic foot infections, patients are treated for 2-6 weeks or longer. Many products effective against MRSA are often available only in IV formulations and can cause significant toxicities. "Contezolid and contezolid acefosamil have shown an excellent safety profile, particularly for reduced potential for hematological toxicities, in our clinical studies and after two years of real-world data on the market in China", said Dr Regis Vilchez, Chief Medical Officer at MicuRx. "We believe that MicuRx can offer an important new choice for DFI treatment with flexibility of oral and IV formulations." For more information, contact [email protected]. About MicuRx Pharmaceuticals, Inc. 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. For more information, please visit the official website of MicuRx Pharmaceuticals at . About Contezolid and Contezolid Acefosamil Contezolid tablets and MRX-4 are innovative 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 in China, 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. About Diabetic Foot Infections Approximately 18.6 million people worldwide are affected by a diabetic foot ulcer each year, including 1.6 million people in the United States. Neurological, vascular, and biomechanical factors contribute to diabetic foot ulceration. Approximately 50% to 60% of ulcers become infected, with up to 20% of these requiring hospitalization. Between 15-20% of moderate-to-severe infections lead to lower extremity amputations. [1] Every year, more than 1 million people with diabetes lose at least a part of their leg as a consequence of the complications of diabetes. This translates into the estimate that every 20 seconds a lower limb is lost to diabetes somewhere in the world.[2] The direct costs of treating diabetic foot ulcers in the USA are estimated to be $9 billion to $13 billion annually. The 5-year mortality rate for individuals with a diabetic foot ulcer is approximately 30%, exceeding 70% for those with a major amputation.[1] [1] Armstrong et al, JAMA 2023. Diabetic Foot Ulcers - A Review. JAMA. 2023;330(1):62-75. doi:10.1001/jama.2023.10578 [2] Bakker et al, Diabetes Metabolism Research Review 2015. The 2015 IWGDF guidance documents on prevention and management of foot problems in diabetes: development of an evidence-based global consensus. SOURCE MicuRx Pharmaceuticals