Shanghai MicuRx Pharmaceutical Co., Ltd.

SHANGHAI, Nov. 20, 2023 /PRNewswire/ -- Recently, Shanghai MicuRx Pharmaceuticals Co., Ltd. (hereinafter referred to as ＂MicuRx＂) announced that its proprietary antibiotic MRX-5, has enrolled its first subject in the first Phase I clinical trial in Australia. MRX-5 is a new type of benzodiazepine antibiotic used to treat infections caused by NTMs (non-tuberculous mycobacteria). Non-tuberculosis mycobacteria refers to a large class of bacteria, excluding Mycobacteria tuberculosis, which causes chronic lung infections and results in lung damage and high mortality rates. At least 250,000 people worldwide are actively being treated for NTM infections and incidence is increasing globally. To date, more than 190 NTM species and 14 subspecies have been identified, with the most common pathogenic NTMs including the Mycobacterium abscess and the Mycobacterium avium complex. NTM infections require 12-24 months of antibiotic therapy taken multiple times per day. Current treatments result in a high number of adverse reactions, inadequate clinical resolution, poor compliance and poor prognosis. Treatment of NTM patients, especially resistant patients, has significant unmet needs. New antibiotics which have greater efficacy, fewer adverse events and better patient compliance are urgently needed. MicuRx is developing MRX-5 for treatment of refractory NTM infections. Pre-clinical studies have shown that MRX-5 has good antibacterial activity for most common NTM bacteria and good safety in animal toxicology studies. This Phase 1 study, the first human clinical trial of MRX-5, is conducted at the Nucleus Network Research Centre in Australia to assess the safety, tolerance, pharmacodynamic characteristics and food effects of oral MRX-5 in healthy subjects. The trial has previously been approved by the Australian Ethics Commission for Human Research (HREC) and has completed the clinical trial filing at the Therapeutic Goods Administration (TGA). Completion is expected in 2024. MicuRx is committed to advancing our pipeline products to serve the infectious disease and critical care markets where more therapeutic options are needed to address unmet medical needs. SOURCE MicuRx Pharmaceutical

[11-October-2023] FOSTER CITY, Calif., Oct. 11, 2023 /PRNewswire/ -- MicuRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, announces that a poster on our preclinical product, MRX-6038, will be presented at ID Week entitled "In vitro Potency of a Leucyl-tRNA Synthetase Inhibitor, MRX-6038, Against Mycobacterium tuberculosis, Mycobacterium avium, and Mycobacterium abscessus." The poster will be presented by the lead investigator, Dr. Michael Cynamon on behalf of his colleagues, Dr. Carolyn Shoen, Michelle DeStefano, and MicuRx's head of biology, Dr. Wen Wang. The poster number 2148 will be presented on 14 October, 2023 in the scientific section entitled Antimicrobial Novel Agents. 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 MRX-6038 MRX-6038 is a new novel leucyl-tRNA synthetase inhibitor with excellent antimicrobial activity against a wide range of Mycobacterium species, including M. tuberculosis, M. avium complex (MAC), and M. abscessus complex (MAb), including known drug-resistant strains. The product is current in preclinical development with a global clinical program in non-tuberculous Mycobacteria (NTM) anticipated for registration in major markets. About Mycobacterial Infections Worldwide, approximately 2 billion people are infected with M. tuberculosis (TB) and 500 million infected with various species of non-tuberculous mycobacterium (NTM) with many infections remaining undiagnosed. Mycobacterium avium complex (MAC) and Mycobacterium abscessus are the most frequently encountered NTM species, and multi-drug resistance is becoming common in NTM and TB. Mycobacteria are challenging, very difficult to treat infections typically found in the lungs, but can appear in the skin, lymph nodes and other locations. Treatment of TB and NTM includes a complicated regimen of 3-4 antibiotics for many months or even years, with limited treatment options. Clinical success rates are typically less than 50% and recurrence or reinfection is common. Drug toxicities are extensive and typically demand treatment modification.[1] Significant unmet needs exist for safer and more effective therapies. According to the WHO, a total of 1.6 million people died from TB in 2021 (including 187 000 people with HIV). Worldwide, TB is the 13th leading cause of death and the second leading infectious killer after COVID-19 (above HIV and AIDS).[1]

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