Shanghai MicuRx Pharmaceutical Co., Ltd.

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 Continue Reading 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 profile after 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 profiles. 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 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

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

FOSTER CITY, Calif., Oct. 8, 2024 /PRNewswire/ -- MicuRx Pharmaceuticals is excited to announce the publication of groundbreaking research on MRX-5, a novel oral oxaborole prodrug, demonstrating significant potential in the treatment of pulmonary infections caused by Mycobacterium abscessus (Mab), a severe nontuberculous mycobacterium (NTM) infection. The research was led by Dr. Gyanu Lamichhane, Associate Professor at Johns Hopkins University School of Medicine. Continue Reading The study, published in Antimicrobial Agents and Chemotherapy, evaluated MRX-5 against clinical isolates of M. abscessus in a validated mouse model. The results revealed that MRX-5 achieved a dose-dependent reduction in lung bacterial burden, with dose of 15 mg/kg showing efficacy comparable to the current standard-of-care. Key Findings: MRX-5 demonstrated significant efficacy against a variety of M. abscessus isolates, including drug-resistant strains, offering hope for patients with limited treatment options. At dose of 15 mg/kg, MRX-5 achieved a reduction in lung bacterial loads comparable to established therapies. MRX-5 showed dose-linear pharmacokinetics, indicating the potential for predictable and manageable dosing in clinical settings. The study marks the first evaluation of MRX-5, the oral prodrug of MRX-6038, in an animal model, demonstrating MRX-5 is well tolerated and effective over extended treatment durations. "We are excited about the potential of MRX-5 to provide a much-needed new treatment option for patients suffering from Mycobacterium abscessus infections," said Jerry Li, the President of MicuRx Pharmaceuticals. "The oral formulation of MRX-5 represents a critical advancement in NTM therapy, particularly for vulnerable patient populations, including those with cystic fibrosis, bronchiectasis, and immunosuppression, who struggle with existing treatment regimens." Mab infections are notoriously difficult to treat, often requiring prolonged, complex, and poorly tolerated courses of multiple antibiotics. With no FDA-approved treatment for Mab, the results of this study are a promising step towards addressing the growing unmet clinical need for effective and convenient treatment options. Importantly, MRX-5 offers an oral alternative to current treatment regimens that are primarily intravenous and highly toxic, with failure rates exceeding 50%. MRX-5 could vastly improve patient compliance and quality of life compared to the current standard intravenous therapies. MicuRx Pharmaceuticals is committed to advancing the development of MRX-5 and looks forward to initiating clinical trials in patients to further evaluate its safety and efficacy in human subjects. For more information, please contact: MicuRx Pharmaceuticals, Inc. Email: [email protected] 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