SHANGHAI, China, and FOSTER CITY, California, USA – September 19, 2019. MicuRx Pharmaceuticals, Inc., today announced positive top-line results from the pivotal Phase 3 clinical trial in China for its lead antibacterial drug candidate contezolid (MRX-I) in adult patients with complicated skin and soft tissue infection (cSSTI). Contezolid met the primary endpoint of noninferiority compared to linezolid for the clinical cure rate at the test-of-cure visit, and was associated with fewer drug-related hematologic laboratory adverse events. “We are very pleased with the favorable results of this Phase 3 clinical trial which established that contezolid is an effective and safer antibacterial drug,” said Dr. Zhengyu Yuan, President and CEO of MicuRx. “We plan to file a New Drug Application with the National Medical Products Administration (NMPA) of China in the 4th quarter of 2019 for this exciting new drug,” continued Dr. Yuan. Contezolid is an oral oxazolidinone antibiotic designed to treat drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE), while offering physicians and patients a new therapeutic option than currently available oxazolidinone agents. The development of contezolid in China has been designated as a “Significant New Drugs Development Special Project”, and contezolid has also been granted QIDP designation…

FOSTER CITY, California, and SHANGHAI, China -September 9, 2019. MicuRx Pharmaceuticals, Inc., today announced positive top-line results for study MRX4-201, a US Phase 2 randomized, double-blind clinical trial comparing contezolid acefosamil (MRX-4) with linezolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Contezolid acefosamil met all primary and secondary efficacy endpoints with a potentially improved hematologic safety profile. “We sincerely appreciate the participation of the patients and the investigators and their study staff in this Phase 2 clinical trial,” said Dr. Zhengyu Yuan, President and CEO of MicuRx. “We are very pleased with the excellent results of this study and plan to advance contezolid acefosamil into Phase 3 development next year,” continued Dr. Yuan.“The IV and oral formulations of contezolid acefosamil appear to be effective in treating ABSSSI, including MRSA infections, as evaluated by endpoints consistent with FDA and EMA bacterial skin infection clinical trial guidance documents, with a dosing regimen that was safe and well-tolerated,” said Edward Fang, MD, Senior Vice President, Clinical Development. “The Phase 2 data support proceeding to pivotal Phase 3 ABSSSI and diabetic foot infection (DFI) studies, and the lower frequencies of hematologic laboratory abnormalities observed with contezolid acefosamil compared with…

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…