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…

FOSTER CITY, Calif. and SHANGHAI, China – September 21, 2018 – MicuRx Pharmaceuticals, Inc. today announced the receipt of the qualified infectious disease product (QIDP) classification and grant of fast track status by the U.S. Food and Drug Administration (FDA) for contezolid (MRX-I) and its prodrug contezolid acefosamil (MRX-4) for the treatment of acute bacterial skin and skin structure infections (ABSSSI). QIDP designation is granted under the U.S. Generating Antibiotic Incentive Now (GAIN) Act, which is part of the FDA Safety and Innovation Act of 2012 (FDASIA). The Act provides incentives for the development of antimicrobials active against priority bacterial pathogens, and includes Fast Track designation for review and five years of market exclusivity added to any non-patent exclusivity. “MicuRx is proud to have received QIDP and Fast Track designation for our oxazolidinone agents, contezolid and the prodrug contezolid acefosamil,” commented Mike Gordeev, Ph.D., MicuRx’s Chief Scientific Officer. “We believe that this FDA designation affirms the need for new drugs effective against the priority pathogens methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE).” Contezolid and contezolid acefosamil are next-generation oxazolidinone agents with notably reduced hematologic toxicity, while maintaining the excellent therapeutic efficacy of the class. Contezolid and contezolid acefosamil are…