MicuRx Completes Phase I Trial for MRX-8 Antibacterial in China

Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx") recently announced the successful completion of the Phase I clinical trial of their new injectable polymyxin antibacterial drug, MRX-8, in China. This milestone represents a significant advancement toward MRX-8 becoming a clinically viable option for treating infections caused by multidrug-resistant Gram-negative bacteria (MDR-GNB).

Clinical Trial Highlights
The Phase I clinical trial conducted in China was a randomized, double-blind, placebo-controlled study aimed at assessing the safety, tolerability, and pharmacokinetic properties of MRX-8 in healthy Chinese participants. The trial featured both single ascending dose and multiple ascending dose components, confirming that MRX-8’s drug exposure in the body scales proportionally with the dose administered.

At the anticipated clinical dose of 2.5 mg/kg once daily, MRX-8 demonstrated ideal therapeutic effects against infections caused by MDR-GNB. Importantly, the drug was well-tolerated among healthy Chinese adults. No participants withdrew or ceased participation due to adverse events, and no severe (CTCAE Grade 3 or higher) adverse events were reported. The most common side effects were mild sensory reduction and decreased glomerular filtration rate, all of which were CTCAE Grade 1 and resolved without medical intervention. Only two subjects in the multiple dose group experienced CTCAE Grade 2 adverse events, both of which were injection site reactions.

Implications and Future Directions
Completing the Phase I clinical trial in China is a crucial achievement for MicuRx and underlines the potential of MRX-8 as a safe and effective treatment for MDR-GNB infections. The encouraging results lay a robust foundation for future clinical applications and bolster confidence in MRX-8’s potential to address a significant medical need.

MicuRx plans to integrate the data from both the US and China Phase I clinical trials to guide the next phases of MRX-8's clinical development. The objective is to explore pathways for various indications, aiming to position MRX-8 as a valuable antibacterial drug for treating multidrug-resistant infections. The company is committed to bringing MRX-8 to the market to meet the escalating demand for effective treatments and provide new hope for patients.

About MRX-8
MRX-8 is an innovative injectable polymyxin antibacterial drug developed independently by MicuRx Pharmaceuticals. It is intended for the treatment of severe infections caused by MDR-GNB. Traditional polymyxin drugs are often limited in clinical application due to their high risk of nephrotoxicity and neurotoxicity. Through meticulous structural design, MRX-8 not only maintains or enhances therapeutic efficacy but also significantly reduces these toxic risks.

The Phase I clinical trial completed in the United States in 2022 demonstrated that MRX-8 is effective against various MDR-GNB, including Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumannii.

The Growing Challenge of MDR-GNB
MDR-GNB are a group of Gram-negative bacteria resistant to multiple drugs, making them a substantial public health challenge. Infections caused by these bacteria have a mortality rate five times higher than those caused by conventional Gram-negative bacteria. According to the World Health Organization (WHO), millions of patients face severe health risks due to resistant bacterial infections every year. In healthcare settings, especially in hospitals and intensive care units, these infections lead to high mortality rates and increased treatment costs, significantly straining healthcare systems.

In China, the total number of days of antibiotic treatment for MDR-GNB infections surged from 43 million in 2018 to 68.4 million in 2023, reflecting a compound annual growth rate of 10.3%. The market currently lacks sufficient options for effectively treating these infections, and the severe side effects associated with traditional polymyxin drugs further limit their use. The development and promising clinical trial results of MRX-8 address this critical need, showing excellent safety and tolerability while demonstrating potent antibacterial activity against MDR-GNB, indicating its significant clinical application potential.

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