Wockhardt Limited has announced successful Phase 3 clinical trial results for its novel intravenous antibiotic Foviscu (WCK 4282), marking a significant milestone in the fight against drug-resistant bacterial infections. The antibiotic successfully met its primary endpoint in treating complicated urinary tract infections (cUTI) and acute pyelonephritis caused by Gram-negative bacteria, including extended-spectrum β-lactamase (ESBL)-producing pathogens.

Phase 3 Trial Results and Clinical Performance

In the randomized, double-blind Phase 3 study, Foviscu demonstrated therapeutic equivalence with meropenem, the gold-standard carbapenem widely used for severe drug-resistant Gram-negative infections. The trial results showed impressive clinical outcomes:

This represents the first Phase 3 head-to-head trial of an antibiotic specifically developed for ESBL infections compared directly with meropenem. The study enrolled 323 hospitalized patients with cUTI and acute pyelonephritis across combined Phase 2 and Phase 3 programs, with Phase 2 including 60 patients and Phase 3 encompassing 263 patients.

Addressing Critical Antimicrobial Resistance

The trial results highlight the urgent need for effective alternatives to combat rising antimicrobial resistance in India. Key findings from the patient population include:

• More than half of Enterobacteriales isolates (51.4%) were ESBL-positive
• 33.8% of Gram-negative bacteria were resistant to cefepime
• Most common causative pathogens included Escherichia coli, Klebsiella spp., Enterobacter spp., and Pseudomonas spp.

ICMR data reveals a high burden of ESBLs and rising resistance to commonly used antibiotics such as piperacillin/tazobactam and cefoperazone/sulbactam. This resistance pattern increasingly forces clinicians to rely on carbapenems like meropenem, thereby accelerating carbapenem resistance. Currently, approximately 65 lakh treatment courses of meropenem, piperacillin/tazobactam, and cefoperazone/sulbactam are used annually in India.

Foviscu's Unique Formulation and Development

Foviscu represents a breakthrough as the globally only scientifically developed single-vial dosage form that combines pharmacodynamically optimized and clinically validated doses of tazobactam 2 g and cefepime 2 g. This combination is enabled by proprietary technology designed to ensure safety and efficacy.

The antibiotic has undergone extensive global evaluation through a comprehensive program covering:

• Clinical development across multiple countries
• Pharmacokinetics/pharmacodynamics (PK/PD) studies
• Antimicrobial susceptibility testing methods
• Microbiology studies on global bacterial isolates

Phase 1 and renal impairment studies were conducted in The Netherlands, PK/PD studies in the US, Europe and India, and microbiology studies on global bacterial isolates in the US and India.

Strengthening Wockhardt's Antibiotic Portfolio

With this Phase 3 success, Foviscu becomes the fifth proprietary antibiotic from Wockhardt to complete a registration-enabling Phase 3 study. The company's antibiotic portfolio now includes:

This achievement further strengthens Wockhardt's leadership in antibiotic discovery, with the company maintaining focus on discovering novel medicines for multi-drug resistant infections for over 25 years. All six products in Wockhardt's drug discovery portfolio at various stages of clinical development and commercialization have been granted Qualified Infectious Disease Product (QIDP) status by the US FDA, including WCK 4282.

Regulatory Support and Future Implications

The combined Phase 2/3 trial received partial support from the National Biopharma Mission (NBM), an initiative of the Department of Biotechnology, Government of India. Foviscu's strong activity against ESBL-producing pathogens has been documented in several peer-reviewed publications in leading international journals.

By providing an effective alternative to carbapenems, Foviscu has the potential to reduce carbapenem use and strengthen antibiotic stewardship efforts to curb antimicrobial resistance. This development represents a crucial step forward in addressing the growing challenge of drug-resistant bacterial infections, particularly in healthcare settings where ESBL prevalence remains high.

Wockhardt is preparing for what its leadership calls a defining decade in antibiotic innovation, with an ambitious pipeline designed to address the growing challenge of drug-resistant infections. Chairman Dr Habil Khorakiwala has outlined plans to launch 5-6 new antibiotics over the next 4-5 years, with additional candidates in early development stages.

Strategic Focus on Antibiotic Innovation

The pharmaceutical company has adopted what Khorakiwala describes as a "white-space strategy" in anti-infectives, capitalizing on the market opportunity created as global players have retreated from antibiotics due to low commercial returns. This strategic positioning allows Wockhardt to address both medical need and market opportunity in an area where resistance levels are rising sharply.

"We will have every two years, three years, a new drug coming out for the next 10 to 15 years. I have another two or three drugs which we have not even announced, which are in early stages," Khorakiwala stated during a recent industry event in Mumbai.

The company plans to remain exclusively focused on antibiotics for the next 10-20 years, leveraging its existing expertise and market position in this specialized therapeutic area.

Pipeline Overview and Key Candidates

Wockhardt's antibiotic pipeline concentrates heavily on multi-drug resistant (MDR) infections, featuring several novel agents at various development stages:

Additional early-stage candidates include WCK 771 and WCK 2349, all targeting critical unmet needs for severe bacterial infections.

Zaynich Regulatory Progress

The company's lead candidate Zaynich is currently undergoing a 6-8 month Fast Track USFDA review process, with approval expected by mid-2026. Khorakiwala expressed confidence in achieving a positive outcome for this drug designed to combat life-threatening multi-drug resistant infections.

The Fast Track designation reflects the urgent medical need for new treatment options against increasingly resistant bacterial strains, positioning Zaynich as a potentially significant addition to the limited arsenal of effective antibiotics.

Global Commercialization Strategy

Wockhardt is evaluating multiple approaches for global market entry, including building its own commercial infrastructure in key markets such as the United States. The company has appointed a merchant banker and is conducting discussions with potential partners, though leadership maintains they will pursue independent commercialization if partnership valuations don't reflect the scientific value created.

For the US market specifically, Khorakiwala noted that developing a commercial organization for injectable hospital antibiotics would require focused sales teams of 50-100 people targeting tertiary-care, high-end hospitals. He emphasized that building commercial capabilities is "far easier" than developing the underlying research engine.

Strategic National Asset Positioning

Khorakiwala has positioned Wockhardt's antibiotic research as a strategic national asset, suggesting India could become a global leader with appropriate government support through funding and regulatory reforms. The company advocates for streamlining Phase 3 approvals, which currently take nearly two years in India compared to 5-6 months in the US and Europe.

This regulatory efficiency gap represents a significant challenge for Indian pharmaceutical innovation, potentially delaying patient access to critical new treatments and affecting the country's competitive position in global drug development.

Source: https://www.moneycontrol.com/news/business/we-can-launch-a-new-drug-every-2-or-3-years-wockhardt-chairman-khorakiwala-13778531.html