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  • Zaynich shows over 97...

Zaynich shows over 97 percent efficacy for drug-resistant bacteria: Wockhardt

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-01-13T13:06:48+05:30  |  Updated On 13 Jan 2025 1:06 PM IST
Wockhardt Zaynich successfully treats paediatric cancer patient with recalcitrant blood, liver infection
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Mumbai: Wockhardt has announced that Zaynich (Zidebactam/Cefepime, WCK 5222) demonstrated over 97 percent clinical efficacy in treating seriously ill patients with infections caused by carbapenemresistant (including meropenem-resistant) Gram-negative pathogens in a ground-breaking clinical study.

The study design was unique as it encompassed a range of severe infections, including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra-abdominal infections (cIAI), and complicated urinary tract infections (cUTI). 17% of these patients also had concurrent BSI thus further escalating the therapeutic challenge. The overall clinical efficacy of Zaynich across indications was 98% at the test-of-cure (TOC), which was 7-10 days after completion of treatment, while it was 100% for BSI, HABP/VABP & cIAI and 97.3% for cUTI.

Notably, Zaynich also demonstrated high pathogen eradication rates (microbiological cure) including for tougher-to-treat HABP/VABP (91%) and BSI patients (100%). Taking into account the results from this clinical study as well as several patients successfully treated under compassionate use in India and US, lives of more than 100 critically ill patients, infected with life-threatening XDR Gram-negative infections have been saved with administration of Zaynich.

Conducted across 15 top-rated tertiary care hospitals nationwide, this clinical study exclusively involved patients with confirmed carbapenem-resistant (including meropenem-resistant) infections, identified through advanced molecular rapid diagnostic technologies. The infecting pathogens were a diverse range of extensively drug-resistant (XDR) Gram-negatives such as Acinetobacter spp., Pseudomonas spp., Klebsiella spp., and E. coli. Treatment durations ranged from 7 to 21 days.

The study protocol was duly approved by Drugs Controller General of India (DCGI). This study underscores the potential of Zaynich as a life-saving antibiotic, particularly for carbapenem-resistant infections. Current highly compromised treatment options are colistin and polymyxins, which are marred with significant toxicity and efficacy limitations. The significance of these findings is amplified by the world-wide threat posed by antimicrobial resistance. Zaynich targets all the Gram negative pathogens identified as critical priorities by the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO).

Zaynich, combination of Zidebactam & Cefepime, is Wockhardt’s novel proprietary antibiotic, targeted towards multi-drug resistant Gram-negative infections. It is currently nearing completion of multi-national Phase III study which would support its registration/marketing authorization globally. Earlier, several Phase I studies including clinical pharmacology studies with zidebactam/cefepime were conducted in US.
"As India has significantly higher rates of meropenem-resistant infections, Phase II study was conducted in India to generate a robust evidence of Zaynich’s effectiveness in overcoming the challenge posed by AMR," the Company stated in a BSE filing.

Read also: Miqnaf: CDSCO nod to Wockhardt 3-day treatment for Community-Acquired Bacterial Pneumonia

wockhardtwockhardt newszaynichzidebactamcefepimecarbapenemresistant
Ruchika Sharma
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

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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