Wockhardt Ltd’s flagship antibiotic, Zaynich, has demonstrated groundbreaking efficacy in a global Phase III clinical trial for complicated urinary tract infections. The drug has shown remarkable success in treating multidrug-resistant (MDR) and extensively drug-resistant (XDR) pathogens, positioning Wockhardt as a key player in the global pharmaceutical industry. Following this announcement, the company’s shares surged 10% on January 31, hitting the upper circuit on the BSE.
The Enhance 1 Phase III study involved 530 patients across multiple regions, including the US, Europe, Latin America, China, and India. The study demonstrated a clinical cure rate of 96.8% for Zaynich at the test of cure, conducted 7-10 days after the final dose. Compared to the standard antibiotic meropenem, Zaynich exhibited superior efficacy, achieving a combined clinical and microbiologic cure rate of 89.0%, significantly higher than meropenem’s 68.4%.
This marks the highest-ever combined efficacy observed among FDA-approved antibiotics in the past decade. The drug specifically targets Gram-negative infections and has been developed over 14 years of research and development. Given the rising global concern over antibiotic resistance, this breakthrough represents a major advancement in treating severe infections.
Zaynich’s effectiveness extends beyond complicated urinary tract infections, as it has demonstrated 97% clinical efficacy in trials involving meropenem-resistant infections such as hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), and complicated intra-abdominal infections.
With these results, Wockhardt plans to file a New Drug Application (NDA) with the US FDA and a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA). The company’s success in developing a novel antibiotic for global markets establishes it as one of the few Indian pharmaceutical firms to make a significant impact in the field of antibiotic resistance.
As of January 31, 2025, at 1:38 PM, Wockhardt’s shares are locked in the upper circuit at ₹1,416.90 per share, up 10% from yesterday’s closing price.
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Published on: Jan 31, 2025, 4:26 PM IST
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