Wockhardt begins Global Phase 3 clinical study of novel antibiotic WCK 5222

Written by Ruchika Sharma Published On 2022-08-17T12:00:23+05:30 | Updated On 17 Aug 2022 8:51 PM IST

Wockhardt begins Global Phase 3 clinical study of novel antibiotic WCK 5222

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.

Mumbai: Wockhardt has announced 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 countries 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."

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 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 is a research based global pharmaceutical and Biotech Company, headquartered in India. 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. 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.

WockhardtWockhardt newsWCK 5222β-lactam ENHANCERUrinary Tract InfectionsAcute Pyelonephritis

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751