drugset / Press release

Paediatric US Cancer Patient with Recalcitrant Blood and Liver Infection Successfully Treated with Zaynich™ (Zidebactam/Cefepime, WCK 5222)

2025-04-01 · Wockhardt · original wockhardt.com ↗

Wockhardt Limited Registered Office: D-4, MIDC, Chikalthana Chhatrapati Sambhajinagar 431006, India Tel.: +91-22-2653 4444 CIN: L24230MH1999PLC120720 www.wockhardt.com Mumbai, 1st April 2025 Paediatric US Cancer Patient with Recalcitrant Blood and Liver Infection Successfully Treated with Zaynich™ (Zidebactam/Cefepime, WCK 5222) A 15-year-old US patient with Acute Myeloid Leukemia (AML), a type of blood and bone marrow cancer, 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 sever ely 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 o f 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 appro val 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 mark s 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/C efepime, demonstrating its potential in combating drug-resistant infections. About Zaynich™ (Zidebactam/Cefepime, WCK 5222) 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 carbapenem- resistant infections. About Wockhardt’s New Drug Discovery portfolio Over the past 25 years, Wockhardt has dedicated its drug discovery efforts to developing innovative antibiotics for multi -drug resistant infections. This focus has led to the creation of a Wockhardt Limited Registered Office: D-4, MIDC, Chikalthana Chhatrapati Sambhajinagar 431006, India Tel.: +91-22-2653 4444 CIN: L24230MH1999PLC120720 www.wockhardt.com robust portfolio of six products currently at various stages of cli nical development and commercialization, all of which have received Qualified Infectious Disease Product (QIDP) designation from the US FDA. About Wockhardt Wockhardt is a research based Global Pharmaceutical and Biotech company. Wockhardt’s New Drug Discovery programme has focussed on unmet need of Anti-bacterial drugs that are effective against the menace of untreatable superbugs. Wockhardt is the only company in the world where USFDA has given QIDP Status (Qualified Infectious Disease Product) for 6 of our Anti-bacterial discovery programmes – 3 of them are Gram Negative and 3 Gram Positive effective against untreatable “Superbugs”. It has a comprehensive Drug Discovery team and clinical organisation. Wockhardt is employing around ~2600 people and 27 nationalities with presence in USA, UK, Ireland, Switzerland, France, Mexico, Russia and many other countries. It has manufacturing and research facilities in India, USA & UK and a manufacturing facility in Ireland. Wockhardt has a significant presence i n USA, Europe and India, with 79% of its global revenues coming from international businesses.

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