MicuRx Pharmaceuticals, Inc. ("MicuRx"), a clinical-stage biopharmaceutical company focused on developing novel anti-infective therapies for drug-resistant bacterial infections, recently announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for MRX-5, enabling the company to initiate a Phase 2a clinical trial in patients with Mycobacterium abscessus pulmonary disease.

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.

MRX-5 is a novel oral antibacterial agent designed to target NTM. 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 favorable pharmacokinetic and safety profiles in nonclinical and clinical studies.

"The FDA's clearance of our IND for MRX-5 represents an important milestone for MicuRx and for patients suffering from M. abscessus pulmonary disease," said President of MicuRx Jerry (Zhiyue) Li "This approval allows us to advance MRX-5 into a Phase 2a clinical trial,  which aim to assess its safety, and efficacy in patients with M. abscessus pulmonary disease."

The Phase 2a trial is a multicenter study in the United States designed to evaluate MRX-5 in adults with confirmed M. abscessus pulmonary disease. The trial is expected to generate important clinical data to inform subsequent development  milestones.

This IND clearance further expands MicuRx's clinical pipeline of anti-infective drugs, reinforcing the company's commitment to addressing global challenges posed by antimicrobial resistance and difficult-to-treat bacterial infections.