The NDA seeks approval for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria including multidrug-resistant (MDR).
In US and EU, more than 8 million cUTI cases are reported every year, reflecting the global burden of Gram negative infections.
According to the release, amidst the escalating global crisis of antimicrobial resistance (AMR), Zidebactam-Cefepime represents a first-in-class β-lactam enhancer and β-lactam combination, introducing a novel mechanism of action to combat some of the most difficult-to-treat infections particularly those that remain unresponsive to approved antibiotics, including those that are recently approved.
Clinical and non-clinical studies have demonstrated its potent activity against multi-drug resistant (MDR) and extreme drug resistant (XDR) Gram-negative pathogens, including those harbouring NDM carbapenemases and PBP mutations. A Phase II study undertaken has demonstrated its efficacy against diverse carbapenem-resistant infections. The NDA submission follows the successful completion of a pivotal Phase III global clinical trial (ENHANCE 1), conducted across 64 sites in India, USA, Bulgaria, Estonia, Lithuania, Poland, Slovakia, Mexico, and China. The program is supported by a robust clinical development package, including nine Phase I studies conducted in the U.S. and China, a Phase II study conducted in India and a multinational Phase III trial evaluating efficacy in cUTI, including pyelonephritis.
Zidebactam-cefepime has been granted qualified infectious disease product (QIDP) and Fast Track Designation by US FDA. Gram-negative infections have become increasingly difficult to treat due to wide spread resistance to multiple classes of antibiotics. Zaynich has the potential to treat a broad range of infections caused by MDR or XDR pathogens including Enterobacterales and Pseudomonas aeruginosa and A. baumannii.
Zaynich, combination of Zidebactam & Cefepime, is Wockhardt’s novel proprietary antibiotic, targeted towards multi-drug resistant Gram-negative infections. Zaynich is a novel β-lactam enhancer mechanism of action drug, which overcomes all the clinically important resistance mechanisms in Gram negative pathogens including tough-to-treat Pseudomonas, Stenotrophomonas, Acinetobacter and Klebsiella. Such spectrum of activity of Zaynich has been documented through >100 publications/presentations, majority from US and EU based independent experts/organizations.
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