Drugmaker Wockhardt said its investigational antibiotic Zaynich (Zidebactam/Cefepime WCK 5222) was successfully used to treat a cancer patient in the United States, who had chronic bilateral thigh infection caused by an extreme-drug resistant pseudomonas.
This marked the first instance in the US, where Zaynich had been used to combat a complex infection caused by extreme-drug-resistant pseudomonas, the company said. The announcement on Friday, sent Wockhardt’s stock price soaring on Monday, over 19 per cent on the BSE, at ₹817 (12.23 pm).
Giving details, the company said, a young immune-compromised cancer patient, who had been hospitalized for nearly nine months at Children’s Hospital of Orange County, University of California Irvine School of Medicine was successfully treated with four weeks of Zaynich (Zidebactam/Cefepime- WCK 5222) for chronic thigh infection under compassionate use, enabling doctors to resume chemotherapy.
Wockhardt also said, at a recent plenary session of the Clinical and Laboratory Standards Institute (CLSI), Zaynich (WCK 5222) had been granted “a susceptibility breakpoint of 64 mg/L for around 10 Gram negative pathogens showing high resistance rates.”
Explaining this, the company said, that susceptibility breakpoints guide the doctors about selection of the most efficacious antibiotic for treating various infections caused by different pathogens. “A high breakpoint of 64 mg/L suggests Zaynich’s (Zidebactam/Cefepime- WCK 5222) 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 the first time that an antibiotic has been granted a susceptible breakpoint of as high as 64 mg/L for all three families of Gram-negative pathogens; Enterobacterales, Pseudomonas and Acinetobacter, the company said.
Currently, Zaynich (Zidebactam/Cefepime- WCK 5222) is undergoing a multinational Phase 3 study, which is expected to be completed by FY 2025, facilitating its global registration and marketing authorization, Wockhardt said.
In the last year, this investigational drug has been successfully used to treat 30 patients under compassionate use who had 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, it said.
Facilitate compassionate use
“Pending Zaynich’s (Zidebactam/Cefepime- WCK 5222) formal approval, CLSI has designated these breakpoints as Investigational Breakpoints to facilitate clinical trials and compassionate use of this life saving antibiotic,” it said.
Over eight years of research data on Zaynich (Zidebactam/Cefepime- WCK 5222) was reviewed by three sub-committees of CLSI sequentially, followed by independent rounds of voting by members at each stage. “The final plenary session unanimously approved the investigational breakpoints for Zaynich (Zidebactam/Cefepime- WCK 5222),” Wockhardt said.
