Wockhardt's Zaynich Demonstrates Superior Efficacy in Phase III cUTI Trial
Key Insights
Wockhardt's Zaynich (zidebactam/cefepime (search)) achieved superiority over meropenem in a Phase III trial for complicated urinary tract infections (search) (cUTI).
The ENHANCE 1 study showed Zaynich had an 89.0% efficacy rate in combined clinical and microbiological cure, compared to 68.4% for meropenem.
Zaynich exhibited a 96.8% clinical cure rate and a safety profile comparable to meropenem in the multi-center trial across the US, Europe, and Asia.
Wockhardt's investigational antibiotic, Zaynich (zidebactam/cefepime (search)), has demonstrated superior efficacy compared to meropenem in a global, pivotal Phase III study for complicated urinary tract infections (search) (cUTI). The 'ENHANCE 1' trial, which enrolled 530 patients across 64 sites in the US, Europe, LATAM, China, and India, showed that Zaynich achieved a significantly higher rate of combined clinical and microbiological cure compared to the current gold standard treatment.
The study results revealed that Zaynich achieved an 89.0% efficacy in the USFDA and EMA-defined primary efficacy endpoint, which is the combination of clinical cure and microbiologic eradication at the test of cure (TOC, 7-10 days after the last dose). In comparison, meropenem showed an efficacy of 68.4%. Notably, Zaynich also demonstrated a 96.8% clinical cure rate.
Addressing Gram-Negative Resistance
The increasing prevalence of Gram-negative infections (search), particularly cUTIs, and the rise of antibiotic resistance, pose a significant challenge to healthcare systems globally. Zaynich's novel β-lactam enhancer mechanism of action offers a potential solution for treating a broad range of patients with cUTI caused by multidrug-resistant (MDR) or extensively drug-resistant (XDR) pathogens, including Enterobacterales (search) and Pseudomonas aeruginosa. In the US and EU, over 8 million cUTI cases are reported annually, highlighting the substantial burden of these infections.
Compassionate Use and Expanded Access
Prior to formal approval, Zaynich has been used under compassionate use programs to treat 45 patients in India and the US with life-threatening infections unresponsive to available antibiotics. The drug has also shown promising results in treating infections caused by carbapenem-resistant bacteria, with a reported 97% clinical efficacy in a study across 15 tertiary care hospitals in India. This included 100% efficacy in treating bloodstream infections (search), hospital-acquired bacterial pneumonia (search), and complicated intra-abdominal infections, and 97.3% efficacy in complicated urinary tract infections (search).
Regulatory Pathway
Based on the Phase III study results, Wockhardt intends to file a new drug application (NDA) with the USFDA and a marketing authorization application (MAA) with the EMA. Zaynich has already received Qualified Infectious Disease Product status from the US FDA, along with five other products in Wockhardt’s portfolio. The company anticipates potentially launching the drug in the market sometime in 2026, pending regulatory approvals.