USFDA grants fast track designation to Wockhardt novel antibiotic WCK 6777
Mumbai: Wockhardt has announced that its unique once-a-day, β-lactam enhancer based MDR-active antibiotic, WCK 6777 (Ertapenem/Zidebactam) has successfully completed a Phase I study conducted by the Division of Microbiology and Infectious Diseases (DMID) at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in US.
Recognizing the therapeutic potential of WCK 6777 for infections caused by MDR Gram negative pathogens, DMID of NIH had selected this drug for Phase I studies. Zidebactam has already demonstrated promising safety profile in Phase I and on-going Phase II & III studies in combination with Cefepime (WCK 5222).
Additionally, recognizing its potential to meet significant unmet medical needs, the US FDA has recently granted Fast Track designation to WCK 6777 for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI).
WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient- parenteral antimicrobial therapy (OPAT) in ambulatory settings. WCK 6777 is active against entire range of meropenem-resistant Gram negative pathogens generally encountered in community as well as hospital urinary tract infections (UTI) and intra-abdominal infections (IAI). Such a therapeutic option is expected to cut hospital admissions, facilitate early patient discharge and thus offer patient-centred care for MDR infections.
Phase I study of WCK 6777 involved 52 participants and was designed as a double-blind, placebo-controlled, multiple-ascending dose trial in healthy volunteers. The trial rigorously assessed the safety and pharmacokinetics of WCK 6777, administering intravenous doses higher than the anticipated clinical dose over a period of 7 days. Results demonstrated a promising safety profile, with WCK 6777 (up to 3 grams + 3 grams daily) being well-tolerated, and no serious or unexpected adverse events reported. None of the subjects withdrew or >
Pharmacokinetic analysis revealed consistent exposure levels of both ertapenem and zidebactam, with no significant interactions when co-administered daily for the duration of the study.
The promising safety data from this study paves the way for the advancement of WCK 6777 into Phase II / III clinical trials.
Globally, incidence of UTI were 404.61 million with 236,790 deaths estimated in 2019. It is estimated that 1 in 100 of US adults will experience a cUTI each year, resulting in approximately 2.8 million cUTI cases and annualized total US costs in excess of $ 6 billion. There are 600,000 hospital admissions among adults for cUTIs each year in the United States with each episode costing an average of $ 9,441.
Emerging therapeutic role of WCK 6777 makes it uniquely positioned to cater to the vast unmet need in the management of infections outside the hospital.
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