Wockhardt stock rose more than 9% after the company stated that the Central Drugs Standard Control Organisation (CDSCO) has approved the import and marketing of Zaynich® (Zidebactam/Cefepime) in India.
Zaynich is an indigenously discovered and developed antibiotic approved for the treatment of adult patients aged 18 years and above suffering from complicated urinary tract infections (cUTI), including pyelonephritis, as well as cases involving concurrent Gram-negative bacteremia.
The regulatory approval is supported by data from the pivotal ENHANCE-1 Phase 3 clinical trial, a multinational, randomized, double-blind study that compared Zaynich with meropenem in patients with complicated urinary tract infections, including pyelonephritis.
According to the company, the primary composite endpoint of clinical cure and microbiological eradication at the test-of-cure visit was achieved by 89% of patients treated with Zaynich, compared with 68.4% of patients who received meropenem. The study reported a treatment difference of 20.6 percentage points in favour of Zaynich. The test-of-cure assessment was conducted approximately 10 days after completion of treatment.
Among patients who had concomitant bacteremia at baseline, the composite response rate at the test-of-cure visit was reported at 89% in the Zaynich arm, compared with 44% in the meropenem arm.
Prior to the Phase 3 study, Zaynich underwent evaluation in nine Phase 1 clinical studies and a Phase 2 study involving patients with documented meropenem-resistant Gram-negative infections. The Phase 2 trial was conducted across 15 tertiary care hospitals in India and assessed the drug in serious infections, including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra-abdominal infections (cIAI), and complicated urinary tract infections.
Wockhardt stated that the Phase 2 study demonstrated clinical efficacy exceeding 97% across the evaluated infections. The company believes the antibiotic could expand treatment options for carbapenem-resistant infections, an area where available therapies may be associated with toxicity concerns and varying levels of effectiveness.
The company also highlighted that Zaynich is designed to target metallo-β-lactamase (MBL)-mediated resistance, a significant antimicrobial resistance mechanism observed in India and several other regions.
In addition, the Clinical and Laboratory Standards Institute (CLSI) has assigned Cefepime/Zidebactam an investigational susceptible breakpoint of 64 mg/L, which may support its potential activity against certain extensively drug-resistant (XDR) Gram-negative pathogens.
Following the announcement, investors reacted positively, with Wockhardt shares gaining over 9% in trading.