Shares of Wockhardt are likely to be in focus after the company announced positive results from a pivotal Phase 3 clinical trial of its novel antibiotic Foviscu® (WCK 4282), as disclosed in a regulatory filing on Monday, January 27.
In an exchange filing under Regulation 30 of SEBI Listing Regulations, Wockhardt said its intravenous antibiotic Foviscu has successfully met the primary endpoint in a Phase 3 study involving patients with complicated urinary tract infections (cUTI) and acute pyelonephritis caused by Gram-negative bacteria, including ESBL-producing pathogens .
The randomized, double-blind Phase 3 trial compared Foviscu directly with meropenem, a last-line carbapenem antibiotic widely used for severe drug-resistant infections. At the test-of-cure stage, Foviscu achieved a clinical cure rate of 93.23%, compared with 92.31% for meropenem, demonstrating therapeutic equivalence with a similar safety profile, according to the company.
With this milestone, Foviscu becomes Wockhardt’s fifth proprietary antibiotic to complete a registration-enabling Phase 3 trial, following Emrok, Emrok O, Miqnaf and Zaynich. The company highlighted that this is the first Phase 3 head-to-head trial of an antibiotic specifically developed for ESBL infections against meropenem.
The trial enrolled 323 hospitalized patients across Phase 2 and Phase 3, with key pathogens including E. coli, Klebsiella, Enterobacter and Pseudomonas. More than 51% of Enterobacterales isolates were ESBL-positive, underlining the growing challenge of antimicrobial resistance in India.
Wockhardt noted that Foviscu has the potential to reduce reliance on carbapenems and support antibiotic stewardship, especially as resistance to commonly used therapies continues to rise. The drug has also received Qualified Infectious Disease Product (QIDP) designation from the US FDA.
The company added that further regulatory and commercial steps will follow based on the successful Phase 3 outcome.
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