A new experimental antibiotic, Zainich, is making waves in clinical trials. The drug developed by Mumbai-based pharmaceutical giant Wockhardt recently showed 97% effectiveness against drug-resistant infections, giving promise that it could help fight the silent epidemic – antibiotic resistance.

These infections are caused by treatable “superbugs.”

Groundbreaking clinical studies showed that Zaenich treated critically ill patients with infections caused by carbapenem-resistant (including meropenem-resistant) Gram-negative pathogens.

These pathogens are certain types of harmful bacteria called gram-negative bacteria that are resistant to a strong group of antibiotics called carbapenems, including a specific group called meropenem.

In simple terms, these bacteria have developed defenses that make powerful antibiotics unable to kill them, making infections caused by these bacteria very difficult to treat.

Zenich, a combination of two powerful antibiotics zidabactam and cefepime (WCK5222), helped treat several serious infections in the study, including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI). Are included. ), complicated intra-abdominal infection (CIAI), and complicated urinary tract infection (cUTI).

Approximately 17% of these patients also had a concurrent bloodstream infection, adding to the clinical challenge.

The overall clinical efficacy of Zenich across all indications was 98% in the trial of cure (TOC) 7-10 days after completion of treatment, while it was 100% and 97.3% for BSI, HABP/VABP and cIAI. % Was. cutie.

Notably, Zainich also demonstrated high pathogen eradication rates (microbiological cure), including in difficult-to-treat HABP/VABP (91%) and BSI patients (100%).

According to Wockhardt’s official statement, based on this clinical study and cases from patients treated under special compassionate use in India and the US, Zainich has treated more than 100 critically ill patients suffering from severe drug-resistant gram-negative infections. Have helped save the lives of patients.

This clinical study, conducted in 15 tertiary care hospitals across the country, specifically included 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 .

The duration of treatment ranged from 7 to 21 days. The study protocol was approved by the Drugs Controller General of India (DCGI).

With 97% effectiveness against multi-drug-resistant infections, the study highlights the potential of Zainich as a life-saving antibiotic, especially for carbapenem-resistant infections.

The currently available treatment options, colistin and polymyxin, are highly limited due to serious side effects and low efficacy.

The importance of these findings is heightened by the worldwide threat posed by antimicrobial resistance (AMR), in which most people are unable to receive treatment due to extremely stubborn bacterial infections that do not respond to standard drugs.

According to the company, Zainich targets all Gram-negative pathogens identified as critical priorities by the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO).

The new drug candidate is currently close to completing a multi-national Phase III study, which will support its registration and marketing authorization globally. Previously, several Phase I studies, including clinical pharmacology studies with zidabactam and cefepime combination, were conducted in the US.

Since India has a high rate of meropenem-resistant infections, a Phase II study was conducted in India to generate solid evidence of the effectiveness of Zainich.