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Trials & Filings

MicuRx Expands Antibiotic Program

Ph II goes global, Ph I begins in Australia, goal to file IND with FDA

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

MicuRx Pharmaceuticals has begun a global clinical development program for its lead compound MRX-I, a novel oxazolidinone antibiotic for treatment of Gram-positive infections including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE). The Phase II double-blind, multi-center, active comparator-controlled clinical study will enroll more than 200 patients with complicated skin and skin structure infections in China.

MicuRx is also enrolling volunteers in a Phase I bridging study in Australia. This study will be performed in healthy subjects to assess the safety and pharmacokinetics of both single and multiple dose regimens of MRX-I in a non-Chinese population. This bridging study is designed to provide essential clinical data to support the filing of an IND with the FDA for a Phase II study of MRX-I to treat acute bacterial skin and skin structure infections.

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