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
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