Shares of Wockhardt Ltdwere locked in a 10% upper circuit on Friday, January 31, after the company announced a breakthrough with its flagship drug, Zaynich, achieving the highest-ever efficacy in a global Phase III clinical trial for complicated urinary tract infections.

The study, which met its primary endpoint for regulatory approval, has shown remarkable results, the company said in a filing.

Zaynich could play a key role in treating patients suffering from complicated urinary tract infections caused by multidrug-resistant (MDR) or extensively drug-resistant (XDR)  pathogens such as Enterobacterales and Pseudomonas aeruginosa.

Shares of Wockhardt opened 10% higher from its previous closing of ₹1286.95 apiece on the BSE and were locked in the upper circuit at Rs 1415.

The enhance 1 Phase III study, involving 530 patients across multiple regions including the U.S., Europe, Latin America, China, and India, demonstrated a clinical cure rate of 96.8% for Zaynich at the test of cure, 7-10 days after the final dose, Wockhardt added.

When compared to the standard antibiotic meropenem, Zaynich showed superiority, with a combined clinical and microbiologic cure rate of 89.0% for Zaynich versus 68.4% for meropenem.

This achievement represents the highest-ever combined efficacy observed among FDA-approved novel antibiotics in the past decade, signalling a significant step forward in the battle against multidrug-resistant and extensively drug-resistant pathogens, which are increasingly difficult to treat.

Zaynich, used in the treatment of Gram-negative infections, is the result of over 14 years of research and development by Wockhardt to create a novel Gram-negative antibiotic.

This achievement positions the company as one of the few Indian pharmaceutical firms to develop and potentially market a global antibiotic product. The company now plans to file a New Drug Application with the US FDA and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA).

Zaynich has also demonstrated its ability to address a wide range of serious infections. The drug has shown 97% clinical efficacy in trials involving patients with meropenem-resistant infections, including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra-abdominal infections, and complicated urinary tract infections.

The Phase III study results highlight the critical need for effective treatments for Gram-negative infections, which are becoming increasingly resistant to antibiotics.