MicuRx announced 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.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
"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."
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.