Wockhardt announces completion of registration-enabling Phase 3 study of Foviscu

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 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.

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