Wockhardt’s new antibiotic WCK 6777 gains FDA fast track status, completes phase I trial, stocks decline 

Wockhardt Limited announced today that its novel antibiotic WCK 6777 (Ertapenem/Zidebactam) has been granted Fast Track designation by the USFDA for treating complicated urinary tract and intra-abdominal infections. The drug has also successfully completed a Phase I study conducted by the National Institutes of Health (NIH) in the United States.

The shares of Wockhardt Limited were trading at ₹941.35 down by ₹24.15 or 2.50 per cent on the NSE today at 12.11 pm

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WCK 6777, a once-daily β-lactam enhancer, is designed for outpatient parenteral antimicrobial therapy. It targets multi-drug resistant Gram-negative pathogens in both community and hospital settings. The Phase I study, involving 52 participants, demonstrated a promising safety profile with no serious adverse events reported.

The antibiotic is positioned to address the significant unmet need in managing infections outside hospitals. It is active against carbapenem-resistant pathogens, including those producing metallo β-lactamases.

Wockhardt’s drug discovery efforts have resulted in a portfolio of six products at various stages of development, each granted Qualified Infectious Disease Product status by the USFDA. The company’s flagship antibiotic, Zaynich (Cepefime/Zidebactam), is currently undergoing a global Phase 3 study for extreme-drug resistant Gram-negative infections.

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