China-based biopharmaceutical company Shanghai MicuRx Pharmaceutical Co., Ltd. (SHSE:688373) announced on Friday that it has successfully completed a Phase III clinical trial of MRX-4 for injection transitioning to oral Contezolid tablets for treating complex skin and soft tissue infections (cSSTI) in China.
The trial met its primary efficacy endpoint, demonstrating non-inferiority to Linezolid and achieving favourable clinical and microbiological results. MRX-4/Contezolid was shown to have good safety and tolerability, with lower rates of haematological adverse events compared to Linezolid. Mild and transient gastrointestinal and liver enzyme-related adverse events were reported but did not lead to trial withdrawal.
The trial's success positions the company to advance the New Drug Application process in China, potentially enabling MRX-4 for injection's approval and commercialization. This development is expected to address unmet clinical needs and significantly boost revenue in the Chinese market. MicuRx plans further clinical trials to expand indications for MRX-4/Contezolid and enhance its value, including studies on drug-resistant Gram-positive bacterial infections and diabetic foot infections.
Contezolid tablets, approved in China in 2021, and MRX-4 for injection are proprietary oxazolidinone-class antibacterial drugs developed by MicuRx.
Avidity Biosciences prices upsized common stock public offering
Sanofi's SAR402663 granted FDA fast track designation for wet AMD
Endo to share PFI and PFA data at American Orthopaedic Foot & Ankle Society Annual Meeting
Diamyd Medical secures Eurasian patent for insulin-based antigen therapy in type 1 diabetes
Sobi's Biologics License Application for NASP in uncontrolled gout accepted by FDA
Hydrosome Labs announces promising fermentation breakthrough with ultrafine bubbles
Ionis receives FDA Breakthrough Therapy designation for ION582 in Angelman syndrome
AMO Pharma signs licence agreement with PHRI and Venca Research Inc to advance new study in ARVC
Saol Therapeutics receives US FDA Complete Response Letter for SL1009 (DCA) in PDCD
Amgen and Kyowa Kirin release rocatinlimab study results in atopic dermatitis
Hemogenyx Pharmaceuticals partners with Made Scientific to advance CAR-T therapy
Lilly's Jaypirca delivers breakthrough results in front-line CLL trial