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India's Wockhardt Starts Global Phase 3 Study Of Its Super Drug 'WCK 5222' To Treat Antibiotic-Resistant Bacterial Infections
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Mumbai-based pharma company Wockhardt on Tuesday (16 August) announced the successful initiation of global phase 3 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”.
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 US Food and Drug Administration has recognised WCK 5222 can address unmet medical needs and designated it as a Qualified Infectious Disease Product (QIDP) which facilitates rapid approval process.
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.
"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," the company said in a regulatory filing on Tuesday.
"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," the company said.
This global study, which is expected to be completed in 18 months, will have 70 centres worldwide in 11 countries including US, Europe, India, China and Latin America.
“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," said Wockhardt's chairman Habil Khorakiwala.
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