Wockhardt Gets CDSCO Panel Nod To study combination of cefepime and zidebactam.
New Delhi: The drug major Wockhardt has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase II clinical trial of Cefepime/Zidebactam (WCK 5222 for Injection).
This came after the firm presented Phase II clinical trial protocol No. W-5222-202.
WCK 5222 is a combination of cefepime and the novel β-lactam enhancer (BLE) zidebactam. Zidebactam has a dual mechanism of action involving high-affinity penicillin-binding protein 2 (PBP2) binding as well as inhibition of Ambler class A and C enzymes.
Cefepime injection is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.
Cefepime inhibits bacterial cell wall synthesis by covalently binding enzymes responsible for the final step in transpeptidation during peptidoglycan wall synthesis. This binding causes defects in the cell wall leading to autolysis and subsequent death of the organism.
Zidebactam is a β-lactam enhancer antibiotic with a dual mechanism of action involving binding to Gram-negative PBP2 and β-lactamase inhibition. Cefepime combined with zidebactam (WCK 5222) is under clinical development for the treatment of Gram-negative infections.
At the recent SEC meeting for Antimicrobial and Antiviral held on 21st December 2023, the expert panel reviewed the Phase III clinical trial protocol No W-5222-202.
After detailed deliberation, the committee recommended the grant of permission to conduct the clinical trial as presented by the firm.
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