MRX-5 is being developed for the treatment of infections caused by non-tuberculous mycobacteria (NTM).
RT’s Three Key Takeaways:
- Orphan Drug Designation: The FDA has granted Orphan Drug Designation to Shanghai MicuRx Pharmaceutical Co Ltd’s novel benzoxazole antibiotic, MRX-5, in development for the treatment of non-tuberculous mycobacteria (NTM) infections.
- Targeting Drug-Resistant Infections: The antibiotic shows promising antibacterial activity against common NTM strains, with favorable safety profiles, low resistance potential, and high oral bioavailability.
- Accelerated Development: The designation will expedite the clinical development and commercialization of the drug, including benefits like tax credits and market exclusivity, aimed at addressing the increasing global threat of NTM diseases.
Shanghai MicuRx Pharmaceutical Co Ltd announced that MRX-5, its anti-infection drug, has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of non-tuberculous mycobacteria (NTM) infections.
MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by NTM. In recent years, NTM diseases have been increasing and have become one of the major public health threats worldwide. However, current treatment options for NTM infections are limited, and traditional drugs face common challenges such as drug resistance, poor efficacy, and numerous adverse effects.
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MRX-5 is a new drug specifically aimed at treating drug-resistant NTM infections, demonstrating good antibacterial activity against common NTM strains. 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.
Orphan Drug Designation Significance
Orphan Drug Designation applies to drugs used to prevent, treat, or diagnose rare diseases that affect fewer than 200,000 people in the US, including biologics. According to the Orphan Drug Act, applicants who receive Orphan Drug Designation are eligible for various benefits, including tax credits, waivers for certain clinical trial costs, exemption from New Drug Application/Biologics License Application fees, and seven years of market exclusivity after approval.
This designation will help accelerate the clinical development and commercialization process of MRX-5, according to a release from MicuRX. Moving forward, MicuRx will continue to advance the clinical development and commercialization of MRX-5, exploring oral treatment strategies that include MRX-5, with the goal of providing safer and more effective treatment options for patients with NTM infections.
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