MicuRx Pharmaceuticals has received FDA clearance to begin a phase 2a clinical trial of MRX-5, a novel oral antibacterial therapy for patients with Mycobacterium abscessus pulmonary disease.
MicuRx Pharmaceuticals, a clinical-stage biopharmaceutical company developing new treatments for drug-resistant bacterial infections, announced that the FDA has cleared its Investigational New Drug (IND) application for MRX-5. The clearance allows the company to initiate a phase 2a clinical trial evaluating the investigational therapy in patients with Mycobacterium abscessus pulmonary disease, a serious and difficult-to-treat non-tuberculous mycobacterial (NTM) infection.
M abscessus pulmonary disease is associated with high morbidity, lengthy and complex treatment regimens, and limited effective therapeutic options. Current standard-of-care approaches often rely on prolonged multi-drug combinations that are poorly tolerated and frequently yield suboptimal outcomes, underscoring the need for new treatment options.
MRX-5 is a novel oral antibacterial agent designed specifically to target NTM infections. In preclinical studies, the compound demonstrated potent activity against clinical isolates of M abscessus, including strains resistant to existing therapies, and showed favorable pharmacokinetic and safety profiles in nonclinical and clinical evaluations.
Learn more:
“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,” MicuRx President Jerry (Zhiyue) Li, said in a statement. “This approval allows us to advance MRX-5 into a Phase 2a clinical trial, which aims to assess its safety and efficacy in patients.”
FDA clearance of the MRX-5 IND enables MicuRx to advance a Phase 2a trial for a serious NTM lung infection with limited treatment options.
MRX-5 has shown promising preclinical activity against drug-resistant M abscessus strains and favorable safety and pharmacokinetic profiles.
The milestone expands MicuRx’s anti-infective pipeline and reinforces its focus on combating antimicrobial resistance.
The phase 2a study will be a multicenter trial conducted in the United States and will enroll adults with confirmed M abscessus pulmonary disease. Data generated from the study are expected to inform future development milestones for MRX-5.
The IND clearance further strengthens MicuRx’s growing clinical pipeline and highlights the company’s ongoing commitment to addressing antimicrobial resistance and other challenging bacterial infections.
MRX-5 is a next-generation antibacterial agent being developed by MicuRx for the treatment of non-tuberculous mycobacterial infections, including M. abscessus. The compound is designed for oral administration and aims to provide a more effective and tolerable treatment option.
FDA granted orphan drug designation to MRX-5 for the treatment of NTM infections in 2024.
Look for more commentary on this subject.
Stay ahead of emerging infectious disease threats with expert insights and breaking research. Subscribe now to get updates delivered straight to your inbox.
