MicuRx Pharmaceuticals, Inc.

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

SHANGHAI , Oct. 25, 2024 /PRNewswire/ -- Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. (“MicuRx”, 688373.SH) announced the successful completion of Phase I clinical trial of MRX-5 in Australia , a self-developed oral antibacterial agent in development for the treatment of nontuberculous mycobacterial (NTM) infections. Details and Results of the Phase I Clinical Trial in Australia This trial represents the first time MRX-5 was administered to humans in a Phase I clinical trial, conducted at the Nucleus Network Research Center in Australia . This trial evaluated the safety, tolerability, PK and food effect of orally administered MRX-5 at single and multiple oral doses. The results of the phase 1 study indicate that MRX-5 was generally well tolerated among the healthy adult subjects participating in this study. There were no serious adverse events reported and all participants completed the trial, and there were no drug-related adverse events rated CTCAE Grade 3 or higher. The majority of TEAEs were CTCAE Grade 1(mild), and resolved without intervention. Pharmacokinetic analysis showed that MRX-6038, the active metabolite of MRX-5, exhibited linear and predictable pharmacokinetic pro single oral doses ranging from 50mg~1200mg. Food intake did not significantly affect its absorption. Impact of the Study and Future Plans The Phase 1 data supports the further development of MRX-5 ,and boosts confidence in the future application of MRX-5 in treating NTM infections. Currently, NTM infections are increasing globally with relatively few new drug developments targeting this area. MRX-5, specifically developed for treatment of NTM pulmonary disease, has the potential advantages of high specificity, oral bioavailability, low resistance rates, and a favorable safety profile. Moving forward, the company plans to explore an all-oral treatment strategy incorporating MRX-5, with the goal of providing patients with safer and more effective options for treating NTM infections. About MRX-5 MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by non-tuberculous Mycobacteria (NTM). There are many species of NTM, and the incidence and prevalence of NTM diseases are increasing. MRX-5 has shown potent antibacterial activity against NTM pathogens in animal studies and this human trial, along with favorable safety and pharmacokinetic pro Additionally, MRX -5 features minimal interactions, low resistance potential, and high oral bioavailability, making it suitable for long-term use in treating chronic infections. NTM and Its Market Demand NTM refer to a group of mycobacteria other than the Mycobacterium tuberculosis complex and Mycobacterium leprae. To date, over 190 species and 14 subspecies of NTM have been identified. Among them, the most common pathogenic NTM include the Mycobacterium avium complex and Mycobacterium abscessus complex. In recent years, the incidence of NTM infections has been increasing, posing a significant public health threat. [1] NTM infections in humans can lead to lesions in related tissues and organs, with NTM lung disease being the most common manifestation. Currently, the treatment of NTM infections mainly relies on multidrug combination therapy with antibiotics. However, treatment courses are long, and traditional drugs often face challenges such as drug resistance, poor efficacy, and numerous adverse effects. About Shanghai MicuRx Pharmaceutical Co., Ltd. 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 our website at Reference: [1] Chinese Medical Association Tuberculosis Branch. Diagnosis and Treatment Guidelines for Non-tuberculous Mycobacterial Diseases (2020 Edition) [J]. Chinese Journal of Tuberculosis and Respiratory Diseases, 2020, 43(11): 918-946. DOI: 10.3760/cma.j.cn112147-20200508-00570. View original content to download multimedia: SOURCE MicuRx Pharmaceuticals

SAN FRANCISCO, Oct. 18, 2024 /PRNewswire/ -- Dr. Regis Vilchez, Chief Medical Officer of MicuRx Pharmaceuticals, presented the latest advancements of company's development program, MRX-5 and MRX-8, at the BIO Investor Forum (BIF). These development programs offer new potentials for the future treatment of Nontuberculous Mycobacterial (NTM) pulmonary diseases and Pseudomonas aeruginosa (PsA) pulmonary infections. Continue Reading MRX-5, a novel benzoxaborole antibiotic, is developed for the treatment of rare chronic pulmonary disease caused by NTM infection. MRX-5 exhibits excellent antibacterial activity against common NTM pathogens and demonstrates good safety in animal trials.MABC affects approximately 12,000 to 20,000 patients in the US and requires treatment durations exceeding 12 months. MRX-5 holds promise for addressing NTM infections. MRX-8, a novel antibiotic in the polymyxin class, is designed to treat severe infections caused by multidrug-resistant Gram-negative bacteria. Traditional polymyxins are limited in clinical use due to high risks of nephrotoxicity and neurotoxicity. MRX-8, with its novel chemical structure, maintains or improves therapeutic efficacy while significantly reducing these risks. The company also aims to explore the clinical and commercial potential of developing an inhaled formulation targeting chronic lung infections. In mouse models of PsA lung infections, nebulized MRX-8 demonstrated significant reduction in bacterial load in lung tissues, indicating strong bactericidal activity. At the forum, Dr. Regis Vilchez focused on presenting the development progress and future plans for MRX-5 and MRX-8, while analyzing the significant market demand for treatments targeting NTM lung disease and chronic PsA pulmonary infections. These two pipeline products are expected to fill gaps in the treatment of NTM lung disease and chronic PsA pulmonary infections, offering patients safer and more effective new treatment options. MicuRx Pharmaceuticals remains committed to discovering, developing, and commercializing innovative medicines to meet unmet clinical needs, providing patients with differentiated therapeutic solutions. The company will continue to actively advance the development of MRX-5 and MRX-8, aiming to bring these innovative drugs to market as soon as possible, bringing hope to patients worldwide. For more information, please contact: MicuRx Pharmaceuticals, Inc. Website: About MicuRx Pharmaceuticals MicuRx Pharmaceuticals is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative antibiotics for the treatment of multidrug-resistant infections. With a mission to address significant unmet medical needs, MicuRx is advancing a portfolio of drug candidates targeting difficult-to-treat infections. 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