Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study
Diagnostic Center

Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study

Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years

  • By IPP Bureau | February 03, 2025

Zaynich, Wockhardt’s flagship discovery product has successfully completed a global, pivotal, registration-enabling Phase III study and demonstrated superiority compared with meropenem (89.0% vs 68.4%, respectively) in the USFDA and EMA (European Medicines Agency) primary efficacy endpoint defined as the combination of clinical cure and microbiologic eradication at test of cure (TOC, 7-10 days after last dose).

With respect to clinical cure, Zaynich achieved 96.8% efficacy. Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years.

In a 1st for India, this milestone is a culmination of >14 years of end-to-end discovery and development of a novel Gram negative antibiotic by an Indian company to be marketed globally. In this blinded trial, Zaynich was compared with gold standard, meropenem, in which Zaynich met the DCGI-concurred and US FDA/EMA/pre-specified primary efficacy endpoint. Based on this study, Wockhardt intends to file a new drug application (NDA) with the USFDA and marketing authorization application (MAA) with EMA.

The Phase III study ‘ENHANCE 1’ enrolled 530 cUTI patients from US, Europe, LATAM, China and India spanning across 64 sites. Zaynich showed clinical efficacy of 96.8% at test of cure (TOC, 7-10 days after last dose) while in the composite of clinical and microbiology cure (US FDA and EMA defined endpoints), Zaynich showed superiority over meropenem (89.0% vs 68.4%, respectively) reflecting the impact of novel β-lactam enhancer mechanism of action. Zaynich was well-tolerated and showed a meropenem-comparable safety profile.

Gram-negative infections such as cUTI have become increasingly difficult to treat due to widespread resistance to multiple classes of antibiotics. Zaynich has the potential to treat a broad range of patients with cUTI due to multidrug-resistant (MDR) or extensively drug resistant (XDR) pathogens including Enterobacterales and Pseudomonas aeruginosa. In the US and EU, > 8 Million cUTI cases are reported every year, reflecting the global burden of Gram negative infections.

Zaynich has recently shown >97% clinical efficacy in a trial involving patients with confirmed meropenem-resistant infections spanning across hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra- abdominal infections (cIAI), and cUTI. During the past >2 years, under compassionate use, Zaynich has been administered to 45 patients from India and US who were battling life-threatening infections not responsive to any of the available antibiotics. Even before its formal approval, Zaynich has drawn global attention as Wockhardt has been receiving requests to supply the drug for compassionate use from countries such as the US, UK, France, Australia, and Malaysia.

Upcoming E-conference

Other Related stories

Startup

Digitization