MicuRx's Self-developed MRX-5 for NTM Infection Clinical Trial Application Approved

Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. (“MicuRx”, 688373.SH) received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA) for MRX-5 tablets, intended for the treatment of infections caused by non-tuberculous mycobacteria (NTM) sensitive to the drug.
Approval Details:
• Drug Name: MRX-5 Tablets
• Applicant: Shanghai MicuRx Pharmaceutical Co., Ltd.
• Acceptance Number: CXHL2401055
• Notice Number: 2024LP03026
• Indication: Intended for the treatment of infections caused by NTM sensitive to the drug
• Approval Conclusion: The clinical trial application for MRX-5 tablets meets the requirements for drug registration, and the NMPA has approved the company to proceed with clinical trials for this drug
Other Relevant Information:
MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by NTM. NTM includes a variety of species, and the incidence and prevalence of NTM diseases are continuously increasing. Currently, the treatment of NTM infections primarily relies on a combination of multiple antibiotics, requiring prolonged treatment durations, and traditional drugs face widespread issues such as drug resistance, poor efficacy, and numerous side effects. MRX-5 is a novel therapeutic agent for NTM infections with good antibacterial activity against common NTM species. It has also shown potent antibacterial activity against NTM pathogens in both animal studies and human trial, along with favorable safety and pharmacokinetic profiles. Additionally, MRX -5 features minimal interactions, low potential for resistance, and high oral bioavailability, making it suitable for long-term use in treating chronic infections.
MRX-5 has completed Phase I clinical trial in Australia, achieving the expected outcomes. Furthermore, MRX-5 was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) in December 2024.
This proposed randomized, dose-escalation, placebo-controlled Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic profile of single and multiple oral doses of MRX-5 tablets in healthy Chinese subjects and oral MRX-5 tablets in patients with non-tuberculosis Mycobacterium tuberculosis infections, as well as the early bactericidal activity in patients, and the preliminary efficacy.
In the future, the company plans to explore an all-oral treatment strategy that includes MRX-5, aiming to provide a safer and more effective treatment option for patients with NTM infections.