Zaynich (zidebactam/cefepime- WCK 5222) has been granted a susceptibility breakpoint of 64 mg/L for around 10 gram negative pathogens showing high resistance rates by the Clinical and Laboratory Standards Institute (CLSI). Susceptibility breakpoints guide the doctors about selection of the most efficacious antibiotic for treating various infections caused by different pathogens.
Pending Zaynich’s formal approval, CLSI has designated these breakpoints as Investigational breakpoints to facilitate clinical trials and compassionate use of this life saving antibiotic.
A high breakpoint of 64 mg/L suggests Zaynich’s strong potential to cover all the clinically important, extreme drug resistant gram-negative pathogens in seriously ill patients. Since the introduction of penicillin in 1928, more than 250 antibiotics have been approved and used clinically, however, this is 1st time ever that an antibiotic has been granted a susceptible breakpoint of as high as 64 mg/L for all the three families of gram negative pathogens; Enterobacterales, pseudomonas and acinetobacter.
In granting the breakpoints, >8 years of research data on Zaynich was reviewed by three sub-committees of CLSI sequentially, followed by independent rounds of voting by the members at each stage. The final plenary session unanimously approved the investigational breakpoints for Zaynich.
During >1 year, Zaynich, has been successfully used to treat 30 patients under compassionate use who were inflicted with infections caused by extreme-drug resistant gram-negative pathogens, including pseudomonas, Klebsiella, E. coli, acinetobacter, and serratia not amenable to any of the available antibiotics. The high breakpoints assigned to Zaynich are supportive of consistent clinical cure and microbiological eradication demonstrated in these compassionate use patients.
Currently, Zaynich is undergoing a multinational phase 3 study, which is expected to be completed by FY 2025, facilitating its global registration and marketing authorization.
Wockhardt is a research based global pharmaceutical and biotech company. Wockhardt’s new drug discovery programme has focussed on the unmet need of antibacterial drugs that are effective against the menace of untreatable superbugs.
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