SHANGHAI,Oct. 25,2024 -- Recently,ShanghaiMicuRx 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.

About MRX-5

MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections,particularly infections caused by non-tuberculous Mycobacteria (NTM).

There are many species of NTM,and the incidence and prevalence of NTM diseases are increasing. MRX-5 has shown potent antibacterial activity against NTM pathogens in animal studies and this human trial,along with favorable safety and pharmacokinetic profiles. Additionally,MRX -5 features minimal interactions,low resistance potential,and high oral bioavailability,making it suitable for long-term use in treating chronic infections.

NTM and Its Market Demand

NTM refer to a group of mycobacteria other than the Mycobacterium tuberculosis complex and Mycobacterium leprae. To date,over 190 species and 14 subspecies of NTM have been identified. Among them,the most common pathogenic NTM include the Mycobacterium avium complex and Mycobacterium abscessus complex.

In recent years,the incidence of NTM infections has been increasing,posing a significant public health threat.[1] NTM infections in humans can lead to lesions in related tissues and organs,with NTM lung disease being the most common manifestation. Currently,the treatment of NTM infections mainly relies on multidrug combination therapy with antibiotics. However,treatment courses are long,and traditional drugs often face challenges such as drug resistance,poor efficacy,and numerous adverse effects.

About Shanghai MicuRx Pharmaceutical Co.,Ltd.

MicuRx is a biopharmaceutical company focusing on novel therapeutics for infectious diseases. With global independent intellectual property and competitiveness,we are committed to the discovery,development,and commercialization of innovative drugs for unmet medical needs. Since the company was founded in 2007,MicuRx has adhered to the principle of "Better Therapy Through Superior Medicine",focusing on the increasingly serious problem of global antimicrobial resistance.

For more information,please visit our website at www.micurx.com

Reference:

[1] Chinese Medical Association Tuberculosis Branch. Diagnosis and Treatment Guidelines for Non-tuberculousMycobacterial Diseases (2020 Edition) [J]. Chinese Journal of Tuberculosis and Respiratory Diseases,2020,43(11): 918-946. DOI: 10.3760/cma.j.cn112147-20200508-00570.