MicuRx Completes Phase 1 Trial of MRX-5 in Australia

SHANGHAI, Oct. 25, 2024 -- Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", 688373.SH) has announced the successful completion of the Phase I clinical trial for its self-developed oral antibacterial agent, MRX-5, in Australia. MRX-5 is being developed for the treatment of nontuberculous mycobacterial (NTM) infections.

Conducted at the Nucleus Network Research Center in Australia, this trial marks the first human administration of MRX-5. The study aimed to evaluate the safety, tolerability, pharmacokinetics (PK), and the food effect of orally administered MRX-5 at both single and multiple doses.

The study's results revealed that MRX-5 was generally well tolerated by the healthy adult subjects involved. Notably, there were no serious adverse events reported, and all participants completed the trial without experiencing drug-related adverse events rated at CTCAE Grade 3 or higher. Most treatment-emergent adverse events (TEAEs) were CTCAE Grade 1 (mild) and resolved without any intervention. Pharmacokinetic analysis demonstrated that MRX-6038, the active metabolite of MRX-5, showcased a linear and predictable pharmacokinetic profile after single oral doses ranging from 50mg to 1200mg. Additionally, food intake did not significantly impact its absorption.

The successful Phase I data support the further development of MRX-5, boosting confidence in its potential application for NTM infections. Currently, NTM infections are on the rise globally, with limited new drug developments in this area. MRX-5, specifically developed for treating NTM pulmonary disease, offers potential benefits such as high specificity, oral bioavailability, low resistance rates, and a favorable safety profile. Moving forward, MicuRx plans to explore an all-oral treatment strategy incorporating MRX-5, aiming to provide patients with safer and more effective treatment options for NTM infections.

MRX-5 is a novel benzoxazole antibiotic tailored for mycobacteria infections, particularly those caused by non-tuberculous Mycobacteria (NTM). There are numerous species of NTM, and the incidence and prevalence of NTM diseases are on the rise. MRX-5 has shown potent antibacterial activity against NTM pathogens in both animal studies and human trials, coupled with favorable safety and pharmacokinetic profiles. The drug features minimal interactions, low resistance potential, and high oral bioavailability, making it suitable for long-term use in treating chronic infections.

NTM refers to a group of mycobacteria other than the Mycobacterium tuberculosis complex and Mycobacterium leprae. Over 190 species and 14 subspecies of NTM have been identified to date, with the most common pathogenic NTM including the Mycobacterium avium complex and Mycobacterium abscessus complex. In recent years, the incidence of NTM infections has been increasing, presenting a significant public health challenge. NTM infections in humans can cause lesions in related tissues and organs, with NTM lung disease being the most prevalent manifestation. Currently, NTM infections are primarily treated with multidrug combination antibiotic therapy, though these treatments are often lengthy and face challenges such as drug resistance, poor efficacy, and numerous adverse effects.

Shanghai MicuRx Pharmaceutical Co., Ltd. is a biopharmaceutical company dedicated to developing novel therapeutics for infectious diseases. The company prides itself on its global independent intellectual property and competitiveness. Since its founding in 2007, MicuRx has remained committed to the principle of "Better Therapy Through Superior Medicine," addressing the increasingly serious problem of global antimicrobial resistance through the discovery, development, and commercialization of innovative drugs for unmet medical needs.