Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", 688373.SH) announced the successful completion of Phase I clinical trial of MRX-5 in Australia, a self-developed oral antibacterial agent in development for the treatment of nontuberculous mycobacterial (NTM) infections.

Details and Results of the Phase I Clinical Trial in Australia

This trial represents the first time MRX-5 was administered to humans in a Phase I clinical trial, conducted at the Nucleus Network Research Center in Australia. This trial evaluated the safety, tolerability, PK and food effect of orally administered MRX-5 at single and multiple oral doses.

The results of the phase 1 study indicate that MRX-5 was generally well tolerated among the healthy adult subjects participating in this study. There were no serious adverse events reported and all participants completed the trial, and there were no drug-related adverse events rated CTCAE Grade 3 or higher. The majority of TEAEs were CTCAE Grade 1(mild), and resolved without intervention.

Pharmacokinetic analysis showed that MRX-6038, the active metabolite of MRX-5, exhibited linear and predictable pharmacokinetic profile after single oral doses ranging from 50mg~1200mg. Food intake did not significantly affect its absorption.

Impact of the Study and Future Plans

The Phase 1 data supports the further development of MRX-5 ,and boosts confidence in the future application of MRX-5 in treating NTM infections.

Currently, NTM infections are increasing globally with relatively few new drug developments targeting this area. MRX-5, specifically developed for treatment of NTM pulmonary disease, has the potential advantages of high specificity, oral bioavailability, low resistance rates, and a favorable safety profile. Moving forward, the company plans to explore an all-oral treatment strategy incorporating MRX-5, with the goal of providing patients with safer and more effective options for treating NTM infections.