drugset / Press release

Zaynich™ (Zidebactam/Cefepime, WCK 5222) enables US cancer patient undergo successful liver transplant and resume chemotherapy by eradicating dual extreme – drug resistant Gram negative pathogens

2024-12-16 · 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, 16th December 2024 Zaynich™ (Zidebactam/Cefepime, WCK 5222) enables US cancer patient undergo successful liver transplant and resume chemotherapy by eradicating dual extreme-drug resistant Gram negative pathogens In yet another US patient at Houston Methodist Hospital, Texas, Zaynich™ turned out to be a saviour by successfully clearing a chronic bile duct infection, facilitating liver transplant leading to her discharge from the hospital. As per the treating doctor, patient failed to respond to >6 weeks of treatment with high -end antibiotics available in US such as cefiderocol and eravacycline. Thus, the treating team was left with no other option but to deploy Zidebactam/Cefepime (WCK 5222) under compassionate use. In the US, the compassionate use approvals are provided by FDA in the form of individual patient-specific expanded-access IND. The patient, a 73-year-old female with bile duct cancer diagnosed in January 2024, had been undergoing chemotherapy and biliary stent placement . H owever, developed sepsis and liver abscess as well as cholangitis (an inflammation of the bile ducts) caused b y extensively drug resistant Pseudomonas aeruginosa and Klebsiella pneumoniae. She received several broad spectrum antibiotics for >6 weeks but continued to have fever and persistent infection markers precluding liver transplant procedure. 15 days of treat ment with Zaynich ™ helped control infectious processes and cleared the way for the transplant in this patient. The pathogens from this patient, Pseudomonas aeruginosa and Klebsiella pneumoniae, were found to possess some of the most challenging resistance mechanisms such as IMP, NDM, and OXA-48 which were effectively neutralized by β-lactam enhancer mechanism of Zaynich™. Till date, 45 patients have benefitted under compassionate use of Zidebactam/Cefepime who were suffering from range of life -threatening Gram negative infections. About ZaynichTM (Zidebactam/Cefepime, WCK 5222) ZaynichTM, combination of Zidebactam & Cefepime, is Wockhardt’s novel proprietary antibiotic, targete d towards multi -drug resistant Gram -negative infections. It is currently nearing completion of Phase III study which would support its registration/marketing authorization globally. Earlier, multiple Phase I studies including clinical pharmacology studies with zidebactam/cefepime were conducted in US. ZaynichTM (Zidebactam/Cefepime) is also undergoing a clinical study in India for the treatment of carbapenem-resistant infections. Wockhardt Limited Registered Office: D-4, MIDC, Chikalthana Chhatrapati Sambhajinagar 431006, India Tel.: +91-22-2653 4444 CIN: L24230MH1999PLC120720 www.wockhardt.com About Wockhardt’s New Drug Discovery portfolio Over the period of 25 years, Wockhardt has focused its drug discovery efforts in the area of discovering novel medicines for multi -drug resistant infections. This has resulted in a portfolio of 6 products at various stages of clinical development and commercialization, each of which have been granted Qualified Infectious Disease Product status by 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 in USA, Europe and India, with 79% of its global revenues coming from international businesses.

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