US FDA grants fast track status to Wockhardt's novel antibiotic WCK 6777

Mumbai-based pharma and biotechnology company Wockhardt announced on Monday that its novel antibiotic WCK 6777 (Ertapenem/Zidebactam) has been granted fast-track designation by the United States Food and Drug Administration (USFDA) for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI).

According to the USFDA website, "fast track" designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

The fast-track status comes as the drug completed its Phase 1 trials. The study was 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 the United States.

WCK 6777 is a once-a-day, β-lactam enhancer used for outpatient parenteral antimicrobial therapy (OPAT). OPAT involves treating infections with the administration of intravenous antibiotics in an outpatient setting.

"It is the only drug in the global antibiotic pipeline designed for OPAT in ambulatory settings," the company said.

WCK 6777 targets multi-drug-resistant Gram-negative pathogens in both community and hospital settings. The company reported that the Phase 1 study, involving 52 participants, demonstrated a promising safety profile with no serious adverse events reported.

"The promising safety data from this study paves the way for the advancement of WCK 6777 into Phase II/III clinical trials," the company stated in a regulatory filing on the Bombay Stock Exchange (BSE).

The company added that the antibiotic is positioned to address the significant unmet need in managing infections outside hospitals. "Such a therapeutic option is expected to reduce hospital admissions, facilitate early patient discharge, and thus offer patient-centred care for multi-drug-resistant (MDR) infections," the company stated in the filing.

The fast-tracking of WCK 6777 comes as Wockhardt advances the development of several new antibiotics aimed at combating difficult-to-treat drug-resistant bacterial infections that drive antimicrobial resistance (AMR)-linked mortality and morbidity.

Earlier this month, the pharma company announced that one of its investigational drugs, Zaynich, had successfully treated critically ill patients with drug-resistant meningitis.

The company now has a portfolio of six products at various stages of clinical development and commercialisation, each of which has been granted Qualified Infectious Disease Product status by the USFDA.