This medication has received approval for treating adult patients with complicated urinary tract infections (cUTI), including pyelonephritis, as well as for infections associated with Gram-negative bacteremia.
According to the company, Zaynich® is a domestically developed first-in-class antibiotic aimed at combating drug-resistant Gram-negative infections.
The approval derives from data collected in the pivotal ENHANCE-1 study, a multinational, randomized, double-blind Phase 3 clinical trial designed to assess the efficacy and safety of Zaynich® compared to meropenem in patients experiencing cUTI, including pyelonephritis.
In the study, participants were randomly assigned in a 2:1 ratio to receive either Zaynich® or meropenem.
The trial indicated that Zaynich® demonstrated statistically superior performance to meropenem on the primary endpoint of clinical cure and microbiological eradication during the test-of-cure visit, which took place approximately 10 days after completing therapy.
The primary endpoint was met in 89% of patients treated with Zaynich®, as opposed to 68.4% within the meropenem group, resulting in a 20.6% treatment difference favoring Zaynich®.
Among patients presenting with concurrent bacteremia at baseline, response rates at the test-of-cure visit were 89% in the Zaynich® group, compared to 44% in the meropenem group, underscoring its potential utility in severe and high-risk cases.
Prior to entering Phase 3, Zaynich® underwent evaluation in nine Phase 1 studies and a Phase 2 trial targeting patients with documented meropenem-resistant Gram-negative infections.
The Phase 2 trial was conducted across 15 tertiary care facilities in India and exhibited over 97% clinical efficacy in the treatment of serious infections, including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra-abdominal infections (cIAI), and cUTI.
Wockhardt emphasized that these results underscore Zaynich®’s potential as a life-saving treatment, particularly for carbapenem-resistant infections where existing therapies like colistin and polymyxins are linked with high toxicity and limited effectiveness.
Furthermore, the company noted that Zaynich® is uniquely equipped to tackle metallo-β-lactamase (MBL)-mediated resistance, one of the most challenging and widespread resistance mechanisms in India.
The Clinical and Laboratory Standards Institute has also designated Cefepime/Zidebactam an investigational susceptible breakpoint of 64 mg/L, bolstering its potential application against extensively drug-resistant Gram-negative pathogens in critically ill patients.
