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First Subject Enrolled in Phase 1 Study of MRX-5

  • Written by PR Newswire

SHANGHAI, Nov. 20, 2023 /PRNewswire/ -- Recently, Shanghai MicuRx Pharmaceuticals Co., Ltd. (hereinafter referred to as "MicuRx") announced that its proprietary antibiotic MRX-5, has enrolled its first subject in the first Phase I clinical trial in Australia.

MRX-5 is a new type of benzodiazepine antibiotic used to treat infections caused by NTMs (non-tuberculous mycobacteria). Non-tuberculosis mycobacteria refers to a large class of bacteria, excluding Mycobacteria tuberculosis, which causes chronic lung infections and results in lung damage and high mortality rates.  At least 250,000 people worldwide are actively being treated for NTM infections and incidence is increasing globally.

To date, more than 190 NTM species and 14 subspecies have been identified, with the most common pathogenic NTMs including the Mycobacterium abscess and the Mycobacterium avium complex. NTM infections require 12-24 months of antibiotic therapy taken multiple times per day.  Current treatments result in a high number of adverse reactions, inadequate clinical resolution, poor compliance and poor prognosis. Treatment of NTM patients, especially resistant patients, has significant unmet needs. New antibiotics which have greater efficacy, fewer adverse events and better patient compliance are urgently needed.

MicuRx is developing MRX-5 for treatment of refractory NTM infections.  Pre-clinical studies have shown that MRX-5 has good antibacterial activity for most common NTM bacteria and good safety in animal toxicology studies.

This Phase 1 study, the first human clinical trial of MRX-5, is conducted at the Nucleus Network Research Centre in Australia to assess the safety, tolerance, pharmacodynamic characteristics and food effects of oral MRX-5 in healthy subjects. The trial has previously been approved by the Australian Ethics Commission for Human Research (HREC) and has completed the clinical trial filing at the Therapeutic Goods Administration (TGA).  Completion is expected in 2024.

MicuRx is committed to advancing our pipeline products to serve the infectious disease and critical care markets where more therapeutic options are needed to address unmet medical needs.

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