Wockhardt Shares Tumbled Over 3% After Significant Development in Antibiotic

On October 7, 2024, Wockhardt announced a significant advancement in its antibiotic development, focusing on new treatments for challenging drug-resistant bacterial infections that contribute to antimicrobial resistance (AMR) and its associated health issues. Recently, WCK 6777 (Ertapenem/Zidebactam), a unique once-daily, β-lactam enhancer-based antibiotic for multidrug-resistant (MDR) infections, completed a Phase I study conducted by the Division of Microbiology and Infectious Diseases (DMID) at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in the United States. 

Acknowledging its therapeutic potential against MDR Gram-negative pathogens, the DMID selected WCK 6777 for Phase I trials. Zidebactam has already shown a promising safety profile in Phase I and ongoing Phase II and III studies in combination with Cefepime (WCK 5222). Additionally, the US FDA has granted Fast Track designation to WCK 6777 for treating complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI), recognizing its potential to address significant unmet medical needs.

WCK 6777 is the only once-daily antibiotic in the global pipeline designed for outpatient parenteral antimicrobial therapy (OPAT) in ambulatory settings. It is effective against a wide range of meropenem-resistant Gram-negative pathogens typically found in both community and hospital urinary tract infections (UTI) and intra-abdominal infections (IAI). This therapeutic option is expected to reduce hospital admissions, enable earlier patient discharges, and provide patient-centred care for MDR infections.

The Phase I study of WCK 6777 involved 52 participants and was designed as a double-blind, placebo-controlled, multiple-ascending dose trial with healthy volunteers. It rigorously assessed the safety and pharmacokinetics of WCK 6777, administering intravenous doses higher than the expected clinical dose over seven days. Results indicated a favourable safety profile, with WCK 6777 (up to 3 grams + 3 grams daily) being well-tolerated and no serious or unexpected adverse events reported. No participants withdrew or were discontinued due to treatment-related side effects.

Pharmacokinetic analysis showed consistent exposure levels for both ertapenem and zidebactam, with no significant interactions when co-administered daily throughout the study. The encouraging safety data from this trial paves the way for WCK 6777 to progress to Phase II/III clinical trials. In 2019, there were approximately 404.61 million UTI cases globally, with an estimated 236,790 deaths. In the US, around 1 in 100 adults experience a cUTI each year, leading to approximately 2.8 million cases and over $6 billion in annual healthcare costs. Each year, there are about 600,000 hospital admissions for cUTIs in the United States, with an average cost of $9,441 per episode.

WCK 6777’s emerging therapeutic role positions it uniquely to address the considerable unmet need for managing infections outside hospital settings. On October 07, 2024, Wockhardt shares opened at ₹942.00 and touched the day low of ₹923.70 at 1:42 PM.

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