Wockhardt announced that its novel intravenous antibiotic Foviscu® (WCK 4282) met its primary endpoint in a Phase 3 clinical trial for complicated urinary tract infections. It matched Meropenem, a gold-standard carbapenem, demonstrating therapeutic equivalence. This milestone positions Foviscu® as a potential alternative to combat rising antibiotic resistance and strengthens Wockhardt’s leadership in antibiotic discovery.
Foviscu® Phase 3 Trial Success
Wockhardt’s novel intravenous antibiotic Foviscu® (WCK 4282) has successfully met the primary endpoint in a Phase 3 clinical trial. The trial focused on patients with complicated urinary tract infections (cUTI) and acute pyelonephritis caused by Gram-negative bacteria, including extended-spectrum ß-lactamase (ESBL)-producing pathogens.
Key Trial Results
In a randomized, double-blind Phase 3 study, Foviscu® was directly compared with meropenem. At the Test-of-Cure visit, Foviscu® achieved a high clinical cure rate of 93.23% versus 92.31% with meropenem, demonstrating therapeutic equivalence with a similarly well-tolerated safety profile.
Addressing Antibiotic Resistance
Data indicates a high burden of ESBLs and rising resistance. By providing an effective alternative, Foviscu® has the potential to reduce carbapenem use and strengthen antibiotic stewardship to curb antimicrobial resistance. Approximately 65 lakh treatment courses of meropenem, piperacillin/tazobactam, and cefoperazone/sulbactam are used annually in India.
About Foviscu® (WCK 4282)
Foviscu® is globally the only scientifically developed single-vial dosage form that combines pharmacodynamically optimized and clinically validated doses of tazobactam 2 g and cefepime 2 g. The combined Phase 2/3 trial was partly supported by National Biopharma Mission (NBM), an initiative of Department of Biotechnology, Government of India.
Wockhardt’s Drug Discovery Portfolio
Wockhardt has a portfolio of 6 products at various stages of clinical development and commercialization, each of which have been granted Qualified Infectious Disease Product status by the US FDA.
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