MicuRx Enrolls First Patient in a Phase 2 Clinical Trial in U.S. for Novel Antibiotic, Contezolid Acefosamil
Time:2018-11-26 / View:601 times
FOSTER CITY, Calif. and SHANGHAI, Nov. 26, 2018 /PRNewswire/ — MicuRx Pharmaceuticals, Inc., today announced that the first patient has been enrolled in a Phase 2 clinical trial of contezolid acefosamil for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococci (VRE). Contezolid acefosamil (formerly called MRX-4) is a prodrug of the oral antibiotic contezolid (MRX-I) which is currently in Phase 3 clinical trials in China for the treatment of complicated skin and soft tissue infections.
This Phase 2 trial will enroll up to 200 patients at 7 centers throughout the United States to evaluate the safety and efficacy of the oral and intravenous (IV) formulations of contezolid acefosamil for 10-14 days of therapy compared to linezolid. The study is a multicenter, comparator-controlled, double-blind trial of patients initiated in hospital for treatment of ABSSSI. The study is expected to complete by mid-2019.
“We are pleased to progress contezolid acefosamil into clinical efficacy studies in the USA, and, pending satisfactory results, plan to continue into global Phase 3 studies shortly thereafter,” said Zhengyu Yuan, Ph.D., President and Chief Executive Officer of MicuRx.
“Contezolid acefosamil may become an alternative treatment choice with significantly reduced risk of hematologic toxicity compared to traditional oxazolidinone antibiotics in the treatment of patients with MRSA or VRE infections,” said Barry Hafkin, M.D., Chief Medical Officer of MicuRx. Oxazolidinone antibiotics have been a “blockbuster” category of drugs used for treatment of multidrug-resistant (MDR) Gram-positive infections, despite well-known hematologic toxicity commonly observed after about 14 days of therapy. “MicuRx goal is to offer potent new antibiotics highly effective against MDR organisms and which have a meaningful improvement in safety compared to current treatment options,” explained Dr. Hafkin. “We believe that none of the current oral MDR Gram-positive agents are ideal for efficacy, safety, and oral/IV switch convenience, and that is the problem we aim to solve with the contezolid platform,” continued Dr. Hafkin.
ABSSSI are common, with approximately 10 million outpatient visits and almost 1 million hospitalized patients per year, just in the US alone. According to a Decision Resources Group report, as many as 9% of patients with ABSSSI have cancer, 13% have kidney disease, and up to 39% have diabetes. New oral antibiotic therapies which do not add to the risk of bone marrow toxicity and are not metabolized through the kidney may fill an unmet need for IV-to-oral switch agents to rapidly discharge patients from hospital, or for oral treatment in the outpatient setting for patients with MDR Gram-positive infections.
About Methicillin-Resistant Staphylococcus Aureus (MRSA)
MRSA is one of the world’s most common human bacterial pathogens, responsible for millions of infections and tens of thousands of deaths worldwide in a wide variety of infections such as skin, bone, lung, and bloodstream. While several antibiotics with activity against MRSA are marketed, very few oral agents against serious infections are available. New oral treatment options with improved safety profile are needed for outpatient therapy, as well as for transition from intravenous to oral therapy to maximize patient convenience and minimize hospitalization time and cost.
About MicuRx Pharmaceuticals, Inc.
MicuRx (http://www.micurx.com/) is a privately-held biopharmaceutical company whose mission is to discover and develop antibiotics with improved safety profiles to improve the treatment of resistant bacterial infections. The lead compound, contezolid (MRX-I), a next-generation oxazolidinone targeting methicillin-resistant Staphylococcus aureus (MRSA), was structure-designed to reduce hematological adverse events of this antibiotic class. In 2015, MicuRx completed two independent Phase 2 studies in the US and China for oral contezolid, and in 2016 initiated a Phase 3 study in China for the treatment of complicated skin and soft tissue infections (cSSTI). Contezolid acefosamil (MRX-4) is a prodrug of contezlid and is planned for global development in MDR Gram-positive infections in both oral and intravenous formulations. Both contezolid and contezolid acefosamil have been granted QIDP designation and Fast Track status by the U.S. FDA. The company has corporate offices outside of San Francisco, California, and in Shanghai, China, and research and development facilities in Shanghai, China. The company has raised a total of US$107 million through leading venture capital firms including Morningside Ventures, BVCF, GP Healthcare Capital, GP TMT Capital, 3E Bioventures Capital, and Delian Capital. Visit www.micurx.com for more information.