Wockhardt Zaynich successfully treats paediatric cancer patient with recalcitrant blood, liver infection

Mumbai: Wockhardt has announced that a 15-year-old US patient with Acute Myeloid Leukemia (AML), a type of blood and bone marrowcancer, has been successfully cured of a severe, drug-resistant infection following treatment with Zaynich (Zidebactam/Cefepime, WCK 5222) under compassionate use.

The patient, who had not responded to nine antibiotics across five different classes over a span of 45 days, was left with few treatment options before Zaynich was administered.

This case, treated at St. Jude's Hospital in Memphis, USA, involved a severely immunocompromised patient due to chemotherapy. The infection was traced to abscesses in the liver, which led to recurrent bloodstream infections caused by E. coli producing NDM, a highly resistant variant of metallo-β-lactamase (MBL). Despite the use of multiple antibiotics, including Tigecycline, Plazomicin, Levofloxacin, Cefepime, Gentamicin, Eravacycline, Polymyxin B, and Ceftazidime/avibactam + Aztreonam, the infection persisted.

Given the patient’s critical condition, the medical team sought approval from the US FDA for the compassionate use of Zaynich. Following the approval, the patient was treated with Zaynich for 41 days, resulting in the successful resolution of the infection and a stabilization of the patient's clinical condition. This marks the third US patient to benefit from Zaynich which is attributable to its unique β-lactam enhancer mechanism.

To date, 51 patients with life-threatening Gram-negative infections have been treated successfully under the compassionate use of Zidebactam/Cefepime, demonstrating its potential in combating drug-resistant infections.

Zaynich is a novel, proprietary antibiotic developed by Wockhardt, combining Zidebactam and Cefepime, designed to target multi-drug resistant Gram-negative infections. The drug has recently completed a global, pivotal Phase III study, which is set to support its marketing authorization worldwide. Prior to this, several Phase I clinical pharmacology studies involving Zidebactam/Cefepime were successfully conducted in the United States. Additionally, Zaynich has completed a multi-indication clinical study in India, focusing on the treatment of carbapenemresistant infections.