Wockhardt antibiotic Foviscu successfully met primary endpoint in phase 3 clinical trial

Wockhardt Ltd. on Tuesday, January 27, said its antibiotic Foviscu successfully met the primary endpoint in a phase 3 clinical trial in patients with complicated urinary tract infections and acute pyelonephritis caused by gram-negative bacteria.

With this, Foviscu becomes the fifth proprietary antibiotic from Wockhardt to complete a registration-enabling phase 3 study, following Emrok, Emrok O, Miqnaf and Zaynich, the company said.

"In a randomised, 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% vs 92.31% with meropenem, thereby meeting the primary endpoint and demonstrating therapeutic equivalence with a similarly well-tolerated safety profile," Wockhardt said.

This is the first phase 3 head-to-head trial of an antibiotic specifically developed for extended spectrum lactamase (ESBL) infections compared with meropenem, it added.

As per the Indian Council of Medical Research (ICMR) data, a high burden of ESBLs and rising resistance to commonly-used antibiotics such as piperacillin/tazobactam and ceforperazon/sulbactam, increasingly forcing clinicians to rely on carbapenems and thereby accelerating carbapenem resistance, Wockhardt said.

By providing an effective alternative, Foviscu has the potential to reduce carbapenem use and strengthen antibiotic stewardship to curb antimicrobial resistance, it added. At present around 65 lakh treatment courses of meropenem, piperacillin/tazobactam, and cefoperazone/sulbactam are used annually in India.

Shares of Wockhardt Ltd. were trading 1.2% up at ₹1,368 apiece around 10.40 am. The stock has declined 18.7% in the last six months.

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