Wockhardt Announced Favourable Results from Zidebactam/Cefepime Clinical Trials

Wockhardt Limited, a leading Indian pharmaceutical company, announced positive outcomes from its compassionate use program for Zidebactam/Cefepime, a novel antibiotic combination discovered in India. This program offers valuable insights into the drug’s potential to combat highly resistant bacterial infections.

Treating Critically Ill Patients with XDR Pathogens

Over the past year, Zidebactam/Cefepime was administered to 30 critically ill patients across 24 leading Indian tertiary care hospitals under compassionate use guidelines. These patients battled a range of life-threatening infections caused by multidrug-resistant (MDR) and extensively drug-resistant (XDR) Gram-negative bacteria, including Pseudomonas, Klebsiella, E. coli, Acinetobacter, and Serratia.

Compelling Clinical Data

The program yielded encouraging results. Most patients exhibited significant clinical improvement within 1-2 weeks of initiating Zidebactam/Cefepime therapy. By the treatment’s conclusion, they achieved both clinical and microbiological cure, indicating eradication of the infection. Notably, the drug was well-tolerated even in patients requiring longer treatment durations (up to 11 weeks) for stubborn infections like osteomyelitis.

Tackling Complex Medical Conditions

The program’s significance is further amplified by the complexity of the patients involved. Many had underlying conditions like cancer, organ transplants, and immune suppression, which can further complicate treatment. Additionally, 20 patients had already failed treatment with other powerful antibiotic combinations, and 10 had shown no response to colistin/polymyxin B, a last-resort antibiotic. Eight patients were even in septic shock upon starting Zidebactam/Cefepime therapy.

Global Development and Regulatory Pathway

Zidebactam/Cefepime is currently undergoing multinational Phase 3 clinical trials, a critical step towards global registration and marketing authorisation. This follows the successful completion of Phase 1 studies, including clinical pharmacology evaluations, conducted in the United States.

Addressing a Critical Need

The widespread emergence of MDR and XDR pathogens in hospitals worldwide presents a major therapeutic challenge for healthcare professionals. Wockhardt’s compassionate use program highlights the urgent need for novel, highly effective antibiotics like Zidebactam/Cefepime to effectively manage life-threatening infections in intensive care units (ICUs) and combat the growing threat of antibiotic resistance.

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