Wockhardt initiates Global Phase 3 Clinical Study of novel antibiotic

16 Aug 2022 , 09:01 AM

Wockhardt announced the completion of first site initiation visit for the pivotal Phase 3 global Clinical Study of its novel antibiotic WCK 5222. This is double-blind, multi-center, efficacy, safety, and tolerability study in the treatment of hospitalized adults with complicated urinary tract infections, including acute pyelonephritis. This study will have 70 centres worldwide in 11 countries including US, Europe, India, China and Latin America. This global study is expected to be completed in 18 months. WCK 5222 is being developed to treat serious Gram-negative bacterial infections which are becoming increasingly resistant to antibiotics and pose a grave threat to public health. This super-drug is a combination with new chemical entity, Zidebactam which brings forth a novel &946;-lactam enhancer mechanism to tackle the extreme drug resistant pathogens such as Acinetobacter, Pseudomonas and Klebsiella. The Food and Drug Administration (USA) has recognised WCK 5222 can address unmet medical needs and designated it as a Qualified Infectious Disease Product (QIDP) which facilitates rapid approval process. Once approved, Wockhardt will be the first Indian company to have developed a new drug to be approved and available worldwide including US, Europe, India, China and many other countries. Dr. Habil Khorakiwala, Wockhardts chairman said: We are pleased that WCK 5222 Phase 3 global study has commenced. WCK 5222 is a new class of antibiotic for Gram-negative terrain for complicated Urinary Tract Infections and Hospital Acquired Bacterial Pneumonia (HABP/VABP). Scientific evidence clearly suggest Superdrug WCK 5222, when available will save many lives worldwide. Wockhardt is a research based global pharmaceutical and biotech company. It has manufacturing and research facilities in India, USA & UK and a manufacturing facility in Ireland. Wockhardt has a significant presence in UK, Europe, USA and India, with over 80% of its global revenues coming from international businesses. On a consolidated basis, Wockhardt reported net loss of Rs 67 crore in Q1 June 2022 as against net loss of Rs 12.71 crore in Q1 June 2021. Net sales declined 30.78% to Rs 595 crore in Q1 June 2022 over Q1 June 2021. Shares of Wockhardt were up 2.14% to Rs 236.75 on Friday, 12 August 2022. Powered by Capital Market - Live News