US FDA agrees to abridged clinical Phase III for Wockhardt’s WCK 5222

US FDA agreed to abridged clinical trial for Phase III for Wockhardt’s superdrug antibiotic WCK 5222. This was based on the evaluation by US FDA of its preclinical and clinical data of Phase I establishing safety and clinical scope of efficacy for the drug. WCK 5222 contains Zidebactam coming out of Wockhardt’s Drug Discovery team of 140 strong scientists working for antibiotic research since last 20 years. Wockhardt expects global clinical launch of WCK 5222 during the year 2020-21.

WCK 5222 is a combination of Zidebactam and Cefepime. This superdrug introduces an entire new class of antibiotic treatment. Earlier US FDA has granted a breakthrough fast track clinical trial and approval process (QIDP status) for this superdrug. This drug meets the urgent threat of Carbopenem – resistant Enterobacteriaceae and serious threats like Multidrug-resistant Acinetobacter, Extended spectrum β-lactamase producing Enterobacteriaceae (ESBLs), Drug-resistant Salmonella typhi and Multidrug-resistant Pseudomonas aeruginosa. This is the categorisation based on which US FDA has given this special QIDP status. Wockhardt has taken this antibiotic for a worldwide clinical development. This drug in scientific community is well documented by a large number of oral and scientific poster presentation at ASM Microbe at Boston and ECCMID at Amsterdam and ID week at New Orleans.

One of the constituents of WCK 5222 is Zidebactam, which is an antibiotic with a novel β-lactam enhancer mechanism that facilitates overcoming of multiple resistance mechanisms in Gram negative superbugs, including the most dreaded mechanism called New Delhi metallo β-lactamase (NDM) which renders the last line of antibiotics (carbapenems) ineffective. WCK 5222 is also active against the recently reported colistin-resistant strains of Gram negative pathogens.