Wockhardt's experimental antibiotic demonstrates notable efficacy in worldwide Phase 3 studies

On Friday, Wockhardt revealed major progress with its new antibiotic ZAYNICH (WCK 5222), emphasizing its distinction as the initial new chemical entity (NCE) in the antibiotic sector in 50 years.

An NCE is a fresh drug compound containing a unique active ingredient not yet authorized by any regulatory body globally. It goes through thorough testing to evaluate its safety, effectiveness, and distinctive therapeutic benefits.

The antibiotic ZAYNICH, comprised of Zidebactam and Cefepime, is being tested in worldwide Phase 3 clinical trials to fight superbugs, the most resilient pathogens. ZAYNICH has demonstrated notable success while being provided through compassionate use regulations, according to the company. ZAYNICH is a recently developed antibiotic that is a new chemical entity (NCE), discovered in the past 50 years. Dr. Habil Khorakiwala, Founder Chairman of Wockhardt, stated that they achieved a 100% success rate in saving all the recipients' lives.

A major incident occurred with a young cancer patient at the School of Medicine, University of California Irvine in the USA. The company stated that this patient, who did not respond to other antibiotics, showed improvement after four weeks of taking ZAYNICH. Dr Khorakiwala stated that four weeks after receiving ZAYNICH, the patient showed improvement and was free from infection, with wounds fully healed, enabling them to restart chemotherapy.

Wockhardt expects to finish ZAYNICH's Phase 3 clinical trials worldwide by FY25, with regulatory approvals and a global launch likely by FY26. Dr Khorakiwala explained that they have chosen to promote ZAYNICH in India and other developing markets, while licensing it to a global pharmaceutical company for the US, Europe, and other developed countries.

ZAYNICH has been given a susceptibility breakpoint of 64 mg/L by the Clinical & Laboratory Standards Institute (CLSI) in the USA, the highest ever awarded, concerning the research and development process. This shows how well it works against various Gram-negative pathogens that are resistant.