Wockhardt's Zaynich Achieves Breakthrough in Drug-Resistant Infections for Cancer Patients

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Wockhardt's Experimental Drug Zaynich Shows Breakthrough Results in Treating Drug-Resistant Infections in Cancer Patients




Wockhardt, a Mumbai-based pharmaceutical and biotechnology company, announced on Friday that its investigational drug, Zaynich, successfully treated a young immunocompromised cancer patient in the United States. The patient, hospitalized for nearly nine months at the Children’s Hospital of Orange County, University of California Irvine School of Medicine, was administered Zaynich for four weeks under compassionate use to combat a chronic thigh infection.

The patient, who has a complex medical history including Acute Myeloid Leukemia, chronic kidney disease, and multiple severe infections, saw significant improvement with Zaynich. Despite previous extensive antibiotic use, the infections persisted until Zaynich was introduced under the "Expanded Access IND" provision granted by the USFDA. This marked the first US instance of Zaynich being used to treat a complex infection caused by extreme-drug-resistant Pseudomonas.

Wockhardt stated that after two weeks of treatment with Zaynich, the patient’s thigh wounds showed significant improvement, and eventually, all wounds healed. The drug was well-tolerated, and its successful use allowed the resumption of chemotherapy.

During the June 24, 2024, plenary session of the Clinical and Laboratory Standards Institute (CLSI), Zaynich was granted a susceptibility breakpoint of 64mg/L for around 10 Gram-negative pathogens with high resistance rates. These investigational breakpoints guide doctors in selecting the most effective antibiotics for various infections. To date, approximately 30 patients have been treated with Zaynich under compassionate use, with the drug showing a 100% success rate and no observed side effects.

Currently, Zaynich is undergoing a multinational Phase 3 study expected to be completed by FY2025. Wockhardt plans to apply for formal approval within six months post-trial completion, aiming to market the product globally within eight to ten months of approval. Habil Khorakiwala, founder and Chairman of Wockhardt, emphasized the importance of global collaboration in drug research, noting partnerships with over 30 organizations.

Dr. Mahesh Patel, Director of Drug Discovery Research at Wockhardt, described Zaynich as the "new penicillin," highlighting its development over 25 years. He shared additional success stories, including a case of facial skin necrosis treated effectively with Zaynich at Apollo Chennai.

Wockhardt expects global approval for Zaynich in the US market by mid-FY26, marking a significant milestone in combating drug-resistant infections in critically ill patients.






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