Shanghai MicuRx Pharmaceutical Co., Ltd.

MicuRx showcased the latest research progress on their pipeline products, MRX-5 and MRX-8, at the 7th World Bronchiectasis Conference Three significant study results further support the potential of MRX-5 and MRX-8 in treating Nontuberculous Mycobacteria (NTM) lung disease and Pseudomonas aeruginosa infections DUNDEE, Scotland, July 18, 2024 /PRNewswire/ -- Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx"，688373.SH) presented the latest research progress on their novel antibiotic pipeline products, MRX-5 and MRX-8, at the 7th World Bronchiectasis Conference (WBC) held in Dundee, Scotland, from July 4 to 6, 2024. These research results provide new hope for the future treatment of Nontuberculous Mycobacteria (NTM) lung disease and Pseudomonas aeruginosa infections. Conference Background Continue Reading The World Bronchiectasis Conference is a leading global academic conference focused on the research and treatment of bronchiectasis. This conference brings together top scientists and clinical experts from around the world to discuss the latest research developments, clinical management strategies, and the development of new therapies for bronchiectasis. Research Highlights As a biopharmaceutical company dedicated to developing innovative anti-infective drugs, MicuRx presented three significant research results in poster presentation at the conference. These studies further support the potential of MRX-5 and MRX-8 in the treatment of specific infections： In Vitro and In Vivo Activity of A Novel Leucyl-tRNA Synthetase Inhibitor Against Mycobacterium Abscessus The active drug MRX-6038 was very potent against M. abscessus clinical isolates in vitro with MIC90 0.5 mg/L while the control drug clarithromycin MIC90 was 4 mg/L. MRX-6038 greatly reduced the resistance frequency of standard of care drugs (Ethambutol, Clarithromycin, Rifabutin, Clofazimine, Amikacin, Imipenem, Ciprofloxacin) by more than 10 to 100,000 folds, demonstrating the potential for combination with the background therapy. Oral prodrug MRX-5 was tested in mice with lung infections due to M. abscessus isolates, and efficacy was demonstrated against infections with both clarithromycin-sensitive and clarithromycin non-susceptible isolates. In Vitro Activity of Novel Leucyl-tRNA Synthetase Inhibitor Against Mycobacterium Avium Complex MRX-6038, the major activedrug of MRX-5, has demonstrated potent in vitro activity against Mycobacterium avium clinical isolates including isolates not susceptible to clarithromycin. When MRX-6038 was combined with Clarithromycin, Rifabutin, Amikacin, and Ethambutol, the resistance frequency of these standard of care drugs was greatly reduced to below 6.5×10-11. Further studies are warranted for the evaluation of MRX-6038 for the treatment of Mycobacterium avium pulmonary disease. In Vitro and In Vivo Activity of A Novel Antibiotic In The Polymyxin Class Against Pseudomonas Aeruginosa MRX-8 demonstrated potent in vitro activity against P. aeruginosa including tobramycin and amikacin resistant clinical isolates. In mouse models with P. aeruginosa lung infections of both tobramycin-sensitive and tobramycin-resistant isolates, nebulized MRX-8 treatment significantly decreased bacterial load in the lung tissues, demonstrating bactericidal activity. About MRX-8 MRX-8 is a novel polymyxin antibiotic developed by MicuRx, primarily used to treat severe infections caused by multidrug-resistant Gram-negative bacteria. Traditional polymyxins are limited in clinical use due to nephrotoxicity and neurotoxicity. Through meticulous structural design, MRX-8 not only maintains or enhances therapeutic efficacy but also significantly improves safety by reducing these potential toxic risks. In 2022, MRX-8 completed Phase I clinical trials in the United States. In 2023, it completed Phase I enrollment in China, with primary study results released in June 2024. These trial results indicated that MRX-8 achieved the desired therapeutic levels in the human body at the expected clinical doses for infections caused by Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumannii. Besides systemic administration, the company plans to explore the development of an inhaled formulation of MRX-8 to uncover its clinical and commercial value in targeted treatment of chronic lung infections. About MRX-5 and NTM MRX-5 is a novel benzoxaborole antibiotic developed by MicuRx for infections caused by NTM. NTM is a common pathogen causing bronchiectasis. In recent years, the incidence of NTM diseases has rapidly increased, becoming a significant public health issue. [1] Among diseases caused by NTM, Mycobacterium avium complex and Mycobacterium abscessus complex account for 70%-95% of NTM diseases. [2] The main clinical symptoms of NTM pulmonary infections include persistent cough, sputum production, chest pain, shortness of breath, fatigue, weight loss, and malaise. [1] Preclinical data indicates that MRX-5 has good antibacterial activity against most common NTM pathogens and has demonstrated good safety in animal studies. Additionally, its characteristics of minimal drug interactions, low resistance potential, and oral availability make it an ideal candidate for the treatment of chronic infections. Currently, MRX-5 is undergoing Phase I clinical trials, offering a promising new treatment option for patients with NTM diseases. 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 References： SOURCE MicuRx Pharmaceutical

SHANGHAI, June 19, 2024 /PRNewswire/ -- Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", 688373.SH), a multi-asset biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today announced 3 new studies will be presented at the 7th World Bronchiectasis Conference, taking place from July 4 - 6, 2024 in Dundee, Scotland. The presentations will showcase nonclinical data for MRX-5 and MRX-8. MRX-5 is an oral investigational candidate for the treatment of adults with nontuberculous mycobacteria (NTM) pulmonary diseases. MRX-5 demonstrates potent antimicrobial activity against Mycobacterium avium complex (MAC), the most common NTM pathogen, as well as Mycobacterium abscessus complex (MABC), the more difficult-to-treat NTM. MRX-5 is currently in Phase 1 clinical studies and topline results are expected in late 3Q2024. MRX-8 is a novel compound in the polymyxin class. Nebulized MRX-8 is developed for treating chronic Pseudomonas aeruginosa lung infection in patients with bronchiectasis, including infections caused by drug resistant isolates. Presentations pertaining to MRX-5 and MRX-8: Title: In Vitro And In Vivo Activity Of A Novel Leucyl-Trna Synthetase Inhibitor Against Mycobacterium Abscessus Presenting Author: Regis Vilchez, MD, PhD (MicuRx) Title: In Vitro Activity of Novel Leucyl-tRNA Synthetase Inhibitor Against Mycobacterium Avium Complex Presenting Author: Wen Wang, PhD (MicuRx) Title: In Vitro And In Vivo Activity Of A Novel Antibiotic In The Polymyxin Class Against Pseudomonas Aeruginosa Presenting Author: Wen Wang, PhD (MicuRx) About MicuRx 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 View original content to download multimedia: SOURCE MicuRx Pharmaceuticals Company Codes: Shanghai:688373

According to the World Health Organization (WHO), millions of patients face treatment difficulties or even life-threatening conditions due to resistant bacterial infections each year. MRX-8 not only shows excellent safety and tolerability but also demonstrates strong antibacterial activity against multidrug-resistant Gram-negative. Bacteria ("MDR-GNB"), indicating significant clinical application potential. In China, the total number of days of antibiotic treatment for MDR-GNB infections increased from 43 million days in 2018 to 68.4 million days in 2023, with a compound annual growth rate of 10.3% during this period. SHANGHAI, June 6, 2024 /PRNewswire/ -- Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", 688373.SH) successfully completed the Phase I clinical trial of its self-developed new injectable polymyxin antibacterial drug MRX-8 in China, achieving the expected goals. MRX-8 is primarily used to treat infections caused by multidrug-resistant Gram-negative bacteria. This significant milestone marks a crucial step towards MRX-8 becoming a safe and effective new antibacterial drug. China Phase I Clinical Trial Results The Phase I clinical trial in China was a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of MRX-8 in healthy Chinese subjects. The trial included single ascending dose and multiple ascending dose components, demonstrating that MRX-8's drug exposure in the human body increases proportionally with the dose. The study demonstrated that at the expected clinical dose of 2.5 mg/kg once daily, MRX-8 can achieve ideal therapeutic effects against infections caused by multidrug-resistant Gram-negative bacteria. Moreover, MRX-8 exhibited good safety in healthy Chinese adults. Throughout the study, no subjects withdrew or terminated the trial due to adverse events, and no CTCAE Grade 3 or higher adverse events occurred. The most common adverse events were mild sensory reduction and decreased glomerular filtration rate, all of which were CTCAE Grade 1 and resolved without intervention. Only two subjects in the multiple dose group experienced CTCAE Grade 2 adverse events, both of which were injection site reactions.. The Study's Impact and Future Plans As one of the company's important new drug development product pipelines, the successful completion of the Phase I clinical trial of MRX-8 in China is of great significance. The study results indicate that MRX-8 exhibits good safety in healthy Chinese adults at the expected clinical dose, laying a solid foundation for its future clinical use. The success of this clinical trial not only provides strong data support for subsequent clinical development, but also enhances confidence in its future application in treating multidrug-resistant Gram-negative bacterial infections. This marks a crucial step forward for MRX-8 in becoming a safe and effective new antibacterial drug. The company will combine the results and data from both the US and China Phase I clinical trials to formulate the next steps in MRX-8's clinical development plan. The company will actively explore development pathways for different potential indications, aiming to make MRX-8 a new antibacterial drug with significant clinical value for treating multidrug-resistant Gram-negative bacterial infections, in order to meet the rapidly growing need for clinical treatment. The company is committed to creating maximum value for society and the company, driving MRX-8 towards market availability, and providing new hope for patients. About MRX-8 MRX-8 is a novel injectable polymyxin antibacterial drug independently developed by MicuRx Pharmaceuticals, primarily used to treat severe infections caused by multidrug-resistant Gram-negative bacteria. Traditional polymyxin drugs have limited clinical use due to their high risk of nephrotoxicity and neurotoxicity. MRX-8, through meticulous structural design, not only maintains or improves therapeutic efficacy, but also significantly reduces these toxic risks. Results from the Phase I clinical trial completed in the United States in 2022 showed that MRX-8 achieves ideal therapeutic effects against infections caused by multidrug-resistant Gram-negative bacteria such as Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumannii. Multidrug-Resistant Gram-Negative Bacteria and Market Demand Gram-negative bacteria are resistant to multiple drugs and are increasingly resistant to most available antibiotics. Multidrug-resistant Gram-negative bacteria (MDR-GNB) are a specific class of Gram-negative bacteria whose multidrug resistance is defined as resistance to three or more commonly prescribed antibiotics (ceftazidime, ciprofloxacin, meropenem, gentamicin, ampicillin/sulbactam, or piperacillin/tazobactam). Infections caused by MDR-GNB have a mortality rate five times higher than infections caused by conventional Gram-negative bacteria. Globally, infections caused by multidrug-resistant Gram-negative bacteria have become a major public health challenge. According to the World Health Organization (WHO), millions of patients face treatment difficulties or even life-threatening conditions due to resistant bacterial infections each year. In hospitals and intensive care units, infections caused by resistant Gram-negative bacteria result in high mortality rates and significant treatment costs, posing substantial pressure on healthcare systems. In China, the total number of days of antibiotic treatment for MDR-GNB infections increased from 43 million days in 2018 to 68.4 million days in 2023, with a compound annual growth rate of 10.3%.[1] Currently, the market has limited options for effectively treating multidrug-resistant Gram-negative bacterial infections, and the severe side effects of traditional polymyxin drugs further restrict their clinical use. The development and clinical trial results of MRX-8 address this unmet market need. MRX-8 not only shows excellent safety and tolerability but also demonstrates strong antibacterial activity against multidrug-resistant Gram-negative bacteria, indicating significant clinical application potential. [1] Data source: Frost & Sullivan Analysis View original content: SOURCE MicuRx Pharmaceuticals