MicuRx Announces $7.78M CARB-X Funding and FDA Approval to Initiate Phase I Clinical Trial for Novel Antibiotic MRX-8

Shanghai, China and Foster City, California, USA – August 13, 2020 – Micurx Pharmaceuticals today announced that MRX-8, a novel antibacterial agent developed by the company, has been awarded up to $7.78 million in non-dilutive funding from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global partnership supporting the development of treatments for drug-resistant bacteria. The funding will support Phase I clinical trials and other related studies. Previously, CARB-X had funded research related to the Investigational New Drug (IND) application for MRX-8 in the United States.

Micurx Pharmaceuticals also announced that the U.S. FDA has completed its review of the Investigational New Drug (IND) application for MRX-8 and approved the initiation of the first-in-human clinical trial. The CARB-X funding will be used to support the Phase I clinical trial, as well as the studies necessary to enable future Phase II clinical trials.

MRX-8 is a novel polymyxin-class antibiotic effective against infections caused by multidrug-resistant (MDR) Gram-negative bacteria, including carbapenem-resistant Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii. MRX-8 shares the same antimicrobial spectrum as the existing agents colistin and polymyxin B, with its differentiated advantage lying in reduced nephrotoxicity and neurotoxicity. Polymyxins are currently considered last-line agents for anti-infective therapy; among patients treated with colistin and polymyxin B, the incidence of nephrotoxicity, primarily manifested as acute kidney injury, can be as high as 60%.

In multiple completed preclinical studies, including toxicology studies in non-human primates, MRX-8 has demonstrated superior renal safety. Furthermore, MRX-8 has shown greater efficacy than polymyxin B in animal models of Gram-negative bacterial urinary tract and pulmonary infections.

“We are delighted to partner with CARB-X to meet the global demand for safer and more effective antibacterial agents. CARB-X is a non-profit partnership comprising leading funders and experts in the field of antibacterial research and development. We are deeply grateful for their generous financial and technical support,” said Dr. Zhengyu Yuan, Chairman and Chief Executive Officer of Micurx Pharmaceuticals.

MRX-8 was discovered by the scientific team at Micurx Pharmaceuticals, which holds global intellectual property rights to the compound and its uses. This innovative molecule has progressed from initial conceptual design to the successful completion of its U.S. Investigational New Drug (IND) application, with first-in-human Phase I clinical trials imminent, further demonstrating Micurx Pharmaceuticals’ commitment to developing novel therapies against drug-resistant bacteria. MRX-8 serves as a strong complement to the company’s New Drug Application (NDA)-stage candidate contezolid and its Phase II candidate MRX-4 (contezolid acefosamil), forming a comprehensive product pipeline for the treatment of serious Gram-positive and Gram-negative bacterial infections.

Micurx Pharmaceuticals is a private biotechnology company dedicated to the discovery and development of novel antibiotics with improved safety profiles for treating drug-resistant bacterial infections. Its lead product, contezolid, is a next-generation oxazolidinone antibiotic targeting methicillin-resistant Staphylococcus aureus (MRSA). Through structural optimization, contezolid reduces the hematological adverse effects associated with this class of antibiotics. Micurx has completed two Phase II clinical trials of contezolid in China and the United States. Following the successful completion of its first Phase III clinical trial in China for complicated skin and soft tissue infections (cSSTI), the company submitted a New Drug Application (NDA) in China in late 2019. Micurx has established operational centers in Shanghai, China, and California, USA. For more information, please visit: www.micurx.com.

CARB-X is a global non-profit partnership dedicated to accelerating the early-stage research and development of antibacterial agents to address the growing threat of antibiotic resistance. Led by Boston University, CARB-X is funded by the Biomedical Advanced Research and Development Authority (BARDA), the Wellcome Trust, the German Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care’s Global AMR Innovation Fund (GAMRIF), and the Bill & Melinda Gates Foundation, with in-kind support provided by the National Institute of Allergy and Infectious Diseases (NIAID). From 2016 to 2021, CARB-X will invest up to $500 million to support innovative antibacterials and other therapeutics, vaccines, and rapid diagnostics. CARB-X supports the world’s largest and most innovative preclinical pipeline of products targeting drug-resistant bacterial infections. CARB-X is headquartered at Boston University School of Law. Visit carb-x.org. Follow us on Twitter @CARB-X.

This press release was supported by ASPR/BARDA under Cooperative Agreement No. IDSEP160030 and by the Wellcome Trust. The content is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X, the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), or other CARB-X investors.