The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), United States of America (USA) is supporting a Phase 1 clinical trial of Wockhardt's novel once-a-day, multidrug-resistant (MDR) Gram-negative targeted antibiotic WCK 6777. The trial will be conducted at NIAID's Phase I clinical trial units in the USA. NIAID will sponsor the investigational new drug (IND) application for the study. The Food and Drug Administration (USA) has granted a qualified infectious disease product (QIDP) designation to WCK 6777, which signifies its ability to meet unmet medical need and facilitates faster approval process.
"We are honored that, NIH, USA would support phase 1 clinical development of WCK 6777 which upon development is expected to offer a much needed outpatient-parenteral antimicrobial therapy for MDR infections in ambulatory settings" said Dr Habil Khorakiwala, Founder and Executive Chairman of Wockhardt group. Interestingly, WCK 6777 is a combination of zidebactam and ertapenem and, zidebactam has also been combined with cefepime, the combination designated as WCK 5222. Chief Scientific Officer, Dr Mahesh Patel elaborated that "WCK 6777 operates through a novel β-lactam enhancer action that enables it to overcome several clinically challenging resistance mechanisms in Gramnegative pathogens".
Once-a-day therapeutic profile of WCK 6777 is expected to cut hospital admissions, facilitate early patient discharge and thus introduce patient-centered care for MDR infections. Through independent preclinical studies, WCK 6777 is shown to be active against several carbapenem-resistant Gram-negative pathogens such as Escherichia coli and Klebsiella, which are often the cause of community as well as hospital infections such as urinary tract infections (UTIs). In USA, UTIs alone accounts for about three million annual hospitalizations and are linked to hospital care cost exceeding 2.8 billion USD.
This trial is being funded in whole or in part under NAIID award number HHSN272201500005I.
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