MicuRx Begins Phase III Trial of Oral Antibiotic for MRSA in China

MicuRx Pharmaceuticals began enrolling patients in a Phase III trial of an oral antibiotic targeting drug-resistant skin infections, including MRSA and vancomycin-resistant enterococci. MicuRx plans to use the study results to support an NDA for its MRX-I antibiotic in China, complementing the company’s U.S. clinical program.

The trial plans to enroll 600 patients with complicated infections at more than 40 Chinese centers, comparing 800 mg of oral MRX-I to 600 mg of oral Zyvox (linezolid). Patients will be treated for one to two weeks, with a follow-up observation period of up to 14 days to ensure clearance of the infection and to monitor side effects. Results are expected in early 2018.

In 2015, MicuRx successfully completed two Phase II studies comparing MRX-I to Zyvox in China and the U.S., demonstrating non-inferiority with reduced hematologic toxicity. Most current anti-MRSA agents are administered intravenously, according to the company, which said oral treatment is an unmet medical need.