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Wockhardt's Foviscu Antibiotic Meets Phase 3 Primary Endpoint with 93.23% Clinical Cure Rate
Wockhardt has announced that its fifth novel antibiotic, Foviscu (WCK 4282), successfully met its primary endpoint in a pivotal Phase 3 trial for treating complicated urinary tract infections. The drug demonstrated a clinical cure rate of 93.23%, matching the 92.31% achieved by the gold-standard meropenem, while showing a well-tolerated safety profile. This milestone is significant as it addresses high-resistance ESBL pathogens in a market where approximately 65 lakh treatment courses of similar antibiotics are used annually in India. The drug has already received QIDP designation from the US FDA, enhancing its global commercial potential.
Key Highlights
Foviscu achieved a 93.23% clinical cure rate versus 92.31% for the gold-standard meropenem in Phase 3 trials.
This is Wockhardt's 5th proprietary antibiotic to successfully complete a registration-enabling Phase 3 study.
The trial targeted ESBL-producing pathogens, which accounted for 51.4% of the Enterobacterales isolates in the study.
Foviscu addresses a large domestic market where 65 lakh treatment courses of similar antibiotics are used annually.
The product holds US FDA Qualified Infectious Disease Product (QIDP) status, providing regulatory advantages.
💼 Action for Investors
Investors should monitor the upcoming regulatory filing and approval timelines for Foviscu, as it represents a significant addition to Wockhardt's commercial antibiotic portfolio. The successful Phase 3 result de-risks a key part of the company's R&D pipeline.