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 FindingsThis 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…

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 AustraliaThis 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 PlansThe Phase 1 data supports the further development of MRX-5 ,and boosts…

San Francisco, CA – October 15, 2024 – 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. 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,…

Foster City, CA – Oct. 8, 2024 – 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.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…

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 BackgroundThe 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 HighlightsAs 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 AbscessusThe 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,…

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. 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. Once a new drug is qualified for QIDP, it will be granted two incentive policies: an additional five years of market exclusivity after launch, and a priority review during the review phase. Dr. Zhengyu Yuan, chairman and CEO of MicuRx Pharmaceutical, said, "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…

Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. announced the official launch of its independently developed anti Gram positive bacteria injection MRX-4 phase III clinical trial in China for cSSTI (complex skin and soft tissue infections). The Antibiotics Research Institute of Huashan Hospital affiliated to Fudan University, as the leader unit of this study, enrolled the first subject, This is also the sixth subject enrolled in this clinical trial. The trial of MRX-4 for injection against cSSTI is a multi-center, randomized, double-blind and double simulation phase III clinical trial, which mainly evaluates the safety and effectiveness of MRX-4 for injection in the treatment of cSSTI, and helps MRX-4 for injection to be approved and marketed in Chinese Mainland. MRX-4 for injection can be converted into the active ingredient contezolid in the human body, greatly expanding the usage scenarios. After being launched, it can provide more medication convenience for critically ill patients and patients who are not suitable for oral administration. It is worth noting that the Phase III clinical trial was led by Professor Zhang Yingyuan and Professor Huang Haihui from Huashan Hospital affiliated to Fudan University. Professor Zhang Yingyuan is a lifelong professor and former director of the Antibiotics Research Institute…

On July 25, 2023, MicuRx Pharmaceutical Co., Ltd. announced that its independently developed new drug against Gram positive drug-resistant bacteria - MRX-4 for injection sequential oral Contezolid Tablets, a global phase III clinical trial project for diabetes foot infection indications, was successfully enrolled in the first patient in West China Hospital of Sichuan University in China. The study of MRX-4 sequential Contezolid for injection on the indications of diabetes foot infection is a three-phase, international, multi-center, randomized, double-blind study, which mainly evaluates the safety and effectiveness of MRX-4/Contezolid for injection in moderate or severe diabetes foot infection (DFI). This trial will be conducted at approximately 70 clinical research centers in major countries including China, the United States, and Europe. Starting from 2022, the trial officially began the enrollment of phase III clinical trials worldwide, and in December 2022, drug clinical trial applications were submitted and approved in several EU countries. China, as a constituent country of the global third phase clinical research, will bring more first-hand data to the enrolled subjects, promoting the clinical progress of the experiment. It is worth noting that Professor Ran Xingwu, director of the diabetes Foot Diagnosis and Treatment Center of West China Hospital of…