Wockhardt announces successful initiation of Global Phase 3 Clinical Study of its novel antibiotic WCK 5222 (16 Aug 2022)
2022-08-16 · Wockhardt · original wockhardt.com ↗
Wockhardt Limited Registered Office: D-4, MIDC, Chikalthana Aurangabad - 431006, India Tel.: +91-22-2653 4444 CIN: L24230MH1999PLC120720 www.wockhardt.com Mumbai, 16th August, 2022 Wockhardt announces successful initiation of Global Phase 3 Clinical Study of its novel antibiotic WCK 5222 Wockhardt is pleased to announce the completion of first site initiation visit for the pivotal Phase 3 global Clinical Study of its novel antibiotic WCK 5222. WCK 5222 is a Super -drug which is entirely a new class of antibiotic known as “β-lactam ENHANCER”. 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 countrie s including US, Europe, India, China and Latin America. This global study is expected to be completed in 18 months. Dr. Habil Khorakiwala, Wockhardt’s 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.” About WCK 5222 WCK 5222 is being developed to treat s erious 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 β -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. Wockhardt Limited Registered Office: D-4, MIDC, Chikalthana Aurangabad - 431006, India Tel.: +91-22-2653 4444 CIN: L24230MH1999PLC120720 www.wockhardt.com When 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. About Wockhardt Wockhardt is a research based global pharmaceutical and Biotech Company, headquartered in India. Globally, Wockhardt employs over 5,000 people from 27 nationalities. It has manufacturing and research facilities in India, USA & UK and a manufacturing facili ty in Ireland. Wockhardt has a significant presence in UK, Europe, USA and India, with over 80% of its global revenues coming from international businesses. Wockhardt’s new drug discovery program has focused on unmet need of anti-bacterial drugs that are effective against the menace of untreatable superbugs. The FDA (USA) has granted QIDP status for six antibiotics discovered at Wockhardt, three of them target Gram -negative pathogens and other three target Gram -positive multi -drug resistant pathogens.
The release as fetched from its publisher. wockhardt.com ↗