Wockhardt’s Foviscu Matches Meropenem in Phase 3 Antibiotic Trial

Wockhardt Ltd has announced that its novel intravenous antibiotic, Foviscu (WCK 4282), has successfully met the primary endpoint in a Phase 3 clinical trial. The trial was conducted on patients with complicated urinary tract infections (cUTI) and acute pyelonephritis caused by Gram-negative bacteria, including extended-spectrum β-lactamase (ESBL)-producing pathogens. This achievement positions Foviscu as the fifth proprietary antibiotic from Wockhardt to complete a registration-enabling Phase 3 study.

The Phase 3 trial was a randomized, double-blind study comparing Foviscu directly with Meropenem, a widely used carbapenem for severe drug-resistant Gram-negative infections. At the Test-of-Cure visit, Foviscu achieved a clinical cure rate of 93.23%, while Meropenem showed a cure rate of 92.31%. This demonstrated therapeutic equivalence between the two antibiotics, with both exhibiting a well-tolerated safety profile.

The trial enrolled a total of 323 hospitalized patients, with 60 in Phase 2 and 263 in Phase 3. The most common pathogens identified were Escherichia coli, Klebsiella spp., Enterobacter spp., and Pseudomonas spp. More than half of the Enterobacterales isolates were ESBL-positive, and 33.8% of Gram-negative bacteria were resistant to cefepime. This underscores the urgent need for stronger first-line treatment options in India, where ESBL prevalence is high.

Data from the Indian Council of Medical Research (ICMR) indicate a high burden of ESBLs and rising resistance to commonly used antibiotics such as piperacillin/tazobactam and cefoperazone/sulbactam. This has led to increased reliance on carbapenems like Meropenem, accelerating resistance. By providing an effective alternative, Foviscu has the potential to reduce carbapenem use and support antibiotic stewardship efforts.

The Foviscu development program included Phase 1 and renal impairment studies in The Netherlands, PK/PD studies in the US, Europe, and India, and microbiology studies on global bacterial isolates. The antibiotic has been designated as a Qualified Infectious Disease Product (QIDP) by the US FDA. The combined Phase 2/3 trial received partial support from the National Biopharma Mission, an initiative of the Department of Biotechnology, Government of India.

Wockhardt Ltd has focused its drug discovery efforts on developing novel medicines for multi-drug resistant infections over the past 25 years. The company has a portfolio of six products at various stages of clinical development and commercialization, each granted Qualified Infectious Disease Product status by the US FDA.