Mumbai: Wockhardt announced that its novel intravenous antibiotic Foviscu® (WCK 4282) has successfully met the
primary endpoint in a Phase 3 clinical trial in patients with complicated urinary tract infections (cUTI) and acute pyelonephritis caused by Gram-negative bacteria, including extended-spectrum β-lactamase (ESBL) producing pathogens. ESBL enzymes make many commonly used antibiotics ineffective and are a major cause of difficult-to-treat hospital infections.
With this milestone, Foviscu® becomes the fifth proprietary antibiotic from Wockhardt to complete a registration-enabling Phase 3 study, following Emrok®, Emrok O®, Miqnaf®, and Zaynich®, further strengthening Wockhardt’s leadership in antibiotic discovery space.
In a randomized, double-blind Phase 3 study, Foviscu® was directly compared with meropenem, a “last-line” gold-standard carbapenem widely used for severe drug-resistant Gram-negative infections. At the Test-of Cure visit, Foviscu® achieved a high clinical cure rate of 93.23% versus 92.31% with meropenem, thereby meeting the primary endpoint and demonstrating therapeutic equivalence with a similarly well-tolerated safety profile. This is the first Phase 3 head-to-head trial of an antibiotic specifically developed for ESBL infections compared with meropenem.
ICMR data show a high burden of ESBLs and rising resistance to commonly used antibiotics such as piperacillin/ tazobactam and cefoperazone/sulbactam, increasingly forcing clinicians to rely on carbapenems (meropenem) and thereby accelerating carbapenem resistance. By providing an effective alternative, Foviscu® has the potential to reduce carbapenem use and strengthen antibiotic stewardship to curb antimicrobial resistance. Currently, approximately 65 lakh treatment courses of meropenem, piperacillin/tazobactam, and cefoperazone/sulbactam are used annually in India.
Foviscu® underwent a combined Phase 2 and Phase 3 program which enrolled 323 hospitalized cUTI and AP patients (Phase 2: 60; Phase 3: 263). The most common causative pathogens were Escherichia coli, Klebsiella spp., Enterobacter spp., and Pseudomonas spp. More than half of the Enterobacterales isolates (51.4%) were ESBL-positive, and 33.8% of Gram negatives were resistant to cefepime, underscoring the urgent need for stronger first-line treatment options in India, where ESBL prevalence is high.
