Wockhardt’s Zaynich achieves record-breaking 96.8% clinical cure rate in cUTI Phase III trial

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Wockhardt Limited has announced a major breakthrough in the treatment of (cUTI) with its novel antibiotic Zaynich (Zidebactam/Cefepime, WCK 5222). In a pivotal Phase III clinical trial, Zaynich demonstrated unparalleled efficacy, achieving a 96.8% clinical cure rate, significantly outperforming meropenem, the current gold standard for treating Gram-negative infections.

This milestone not only establishes Zaynich as a leading antibiotic therapy for drug-resistant bacterial infections, but it also marks a historic achievement for India’s . Wockhardt is the first Indian company to develop a Gram-negative antibiotic with global commercialization potential, culminating more than 14 years of dedicated research and clinical development.

How does Zaynich outperform standard treatments for complicated urinary tract infections?

The Phase III study, ENHANCE 1, was conducted across 530 patients in the United States, Europe, Latin America, China, and India to evaluate the effectiveness of Zaynich compared to meropenem. The trial’s primary endpoint, defined by the U.S. Food and Drug Administration () and the European Medicines Agency (EMA), measured a combination of clinical cure rate and microbiologic eradication at the test-of-cure assessment, which occurs 7–10 days after the final dose.

Results from the study showed:

  • Zaynich achieved an 89.0% composite cure rate, significantly higher than meropenem’s 68.4%.
  • When assessed solely on clinical cure rate, Zaynich reached an unprecedented 96.8% efficacy.
  • The antibiotic exhibited a safety profile comparable to meropenem, reinforcing its viability as a frontline treatment for complicated urinary tract infections.
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These results position Zaynich as one of the most effective antibiotics developed in the last decade and a promising solution for addressing antimicrobial resistance in Gram-negative infections.

Why is Zaynich a breakthrough in treating drug-resistant Gram-negative infections?

Antibiotic resistance is one of the most pressing global health challenges, particularly for Gram-negative infections such as cUTI. Bacteria like Enterobacterales and Pseudomonas aeruginosa have developed resistance to multiple drug classes, making existing treatments less effective.

Each year, over 8 million cases of complicated urinary tract infections are reported across the United States and Europe, with rising resistance rates leading to increased hospitalization and treatment failures. Zaynich’s novel β-lactam enhancer mechanism allows it to overcome key resistance mechanisms, making it a potent weapon against multidrug-resistant (MDR) and extensively drug-resistant (XDR) pathogens.

What sets Zaynich apart from existing cUTI treatments?

Zaynich is a proprietary combination of Zidebactam and Cefepime, designed to:

  • Target resistant Gram-negative bacteria, including Pseudomonas, Stenotrophomonas, Acinetobacter, and Klebsiella.
  • Restore antibiotic efficacy against pathogens that have become resistant to traditional β-lactam antibiotics.
  • Provide broad-spectrum coverage, ensuring high clinical success rates even in critically ill patients.
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Extensive research on Zaynich has been validated through over 100 independent studies and clinical presentations, many led by infectious disease specialists in the United States and Europe.

How does Zaynich expand treatment options beyond cUTI?

Beyond complicated urinary tract infections, Zaynich has demonstrated over 97% clinical efficacy in treating patients with confirmed meropenem-resistant infections across multiple indications, including:

  • Hospital-acquired bacterial pneumonia (HABP)
  • Ventilator-associated bacterial pneumonia (VABP)
  • Bloodstream infections (BSI)
  • Complicated intra-abdominal infections (cIAI)

Over the past two years, Zaynich has been used under compassionate use protocols to treat 45 critically ill patients in India and the United States suffering from life-threatening bacterial infections unresponsive to other available treatments.

What are Wockhardt’s next steps for Zaynich approval and commercialization?

Following the success of the Phase III trial, Wockhardt plans to:

  • Submit a New Drug Application (NDA) to the U.S. FDA.
  • File a Marketing Authorization Application (MAA) with the EMA.

Regulatory approval in the U.S. and Europe would allow Zaynich to be introduced as a first-line treatment for drug-resistant Gram-negative infections, addressing the growing global burden of complicated urinary tract infections and related conditions.

Wockhardt has already received international requests from the U.S., U.K., France, Australia, and Malaysia for early access to Zaynich under compassionate use programs, highlighting its potential as a lifesaving antibiotic therapy.

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What is Wockhardt’s broader impact on antibiotic discovery?

For over 25 years, Wockhardt has been a pioneer in developing novel treatments for antibiotic resistance. The company’s portfolio includes six investigational antibiotics, all granted Qualified Infectious Disease Product (QIDP) status by the U.S. FDA, a designation that recognizes drugs addressing serious or life-threatening infections.

With operations spanning the United States, , Ireland, Switzerland, France, Mexico, and Russia, Wockhardt has established itself as a global leader in anti-infective drug discovery, with approximately 79% of its revenue coming from international markets.

How will Zaynich impact the future of antibiotic resistance treatment?

If approved, Zaynich could redefine the standard of care for complicated urinary tract infections and other Gram-negative infections, providing a critical new option for clinicians worldwide.

As antibiotic resistance continues to rise, Zaynich represents a powerful step forward in combating multidrug-resistant bacterial infections, ensuring that patients receive effective treatment even against the toughest drug-resistant pathogens.


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