Clinical-stage biopharmaceutical company MicuRx Pharmaceuticals Inc announced on Thursday that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for MRX-5, a novel oral antibacterial agent being developed for the treatment of non-tuberculous mycobacterial infections, including Mycobacterium abscessus pulmonary disease.

This approval allows MicuRx to commence a Phase 2a clinical trial of the product in patients with M. abscessus. The compound is designed for oral administration and aims to provide a more effective and tolerable treatment option.

M. abscessus pulmonary disease is a serious and prevalent non-tuberculous mycobacterial (NTM) infection associated with high morbidity, prolonged treatment regimens, and limited effective therapeutic options. Current treatments often require multi-drug combinations over extended periods and are frequently complicated by poor tolerability and suboptimal outcomes.

In preclinical studies, MRX-5 demonstrated potent activity against clinical isolates of M. abscessus, including strains resistant to existing standard-of-care therapies. The compound has also shown favourable pharmacokinetic and safety profiles in nonclinical and clinical studies.

The Phase 2a trial, a multicentre study in the United States, is aimed at assessing the product in adults with confirmed M. abscessus pulmonary disease.