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.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA