• According to the World Health Organization (WHO), millions of patients face treatment difficulties or even life-threatening conditions due to resistant bacterial infections each year.
• MRX-8 not only shows excellent safety and tolerability but also demonstrates strong antibacterial activity against multidrug-resistant Gram-negative. Bacteria ("MDR-GNB"), indicating significant clinical application potential.
• In China, the total number of days of antibiotic treatment for MDR-GNB infections increased from 43 million days in 2018 to 68.4 million days in 2023, with a compound annual growth rate of 10.3% during this period.

Recently, Shanghai MicuRx Pharmaceutical  successfully completed the Phase I clinical trial of its self-developed new injectable polymyxin antibacterial drug MRX-8 in China, achieving the expected goals. MRX-8 is primarily used to treat infections caused by multidrug-resistant Gram-negative bacteria. This significant milestone marks a crucial step towards MRX-8 becoming a safe and effective new antibacterial drug.

China Phase I Clinical Trial Results

The Phase I clinical trial in China was a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of MRX-8 in healthy Chinese subjects. The trial included single ascending dose and multiple ascending dose components, demonstrating that MRX-8's drug exposure in the human body increases proportionally with the dose.

The study demonstrated that at the expected clinical dose of 2.5 mg/kg once daily, MRX-8 can achieve ideal therapeutic effects against infections caused by multidrug-resistant Gram-negative bacteria. Moreover, MRX-8 exhibited good safety in healthy Chinese adults. Throughout the study, no subjects withdrew or terminated the trial due to adverse events, and no CTCAE Grade 3 or higher adverse events occurred. The most common adverse events were mild sensory reduction and decreased glomerular filtration rate, all of which were CTCAE Grade 1 and resolved without intervention. Only two subjects in the multiple dose group experienced CTCAE Grade 2 adverse events, both of which were injection site reactions..

The Study's Impact and Future Plans

As one of the company's important new drug development product pipelines, the successful completion of the Phase I clinical trial of MRX-8 in China is of great significance. The study results indicate that MRX-8 exhibits good safety in healthy Chinese adults at the expected clinical dose, laying a solid foundation for its future clinical use. The success of this clinical trial not only provides strong data support for subsequent clinical development, but also enhances confidence in its future application in treating multidrug-resistant Gram-negative bacterial infections. This marks a crucial step forward for MRX-8 in becoming a safe and effective new antibacterial drug.

The company will combine the results and data from both the US and China Phase I clinical trials to formulate the next steps in MRX-8's clinical development plan. The company will actively explore development pathways for different potential indications, aiming to make MRX-8 a new antibacterial drug with significant clinical value for treating multidrug-resistant Gram-negative bacterial infections, in order to meet the rapidly growing need for clinical treatment. The company is committed to creating maximum value for society and the company, driving MRX-8 towards market availability, and providing new hope for patients.