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A new experimental antibiotic called Zaynich is causing a stir in clinical trials. The drug, developed by Mumbai-based pharmaceutical giant Wockhardt, was recently found to be 97 percent effective against drug-resistant infections, showing its potential in tackling a silent epidemic: antibiotic resistance. These infections are caused by “superbugs” that cannot be cured. This groundbreaking clinical trial showed Zaynich treating critically ill patients with infections caused by carbapenem-resistant (including meropenem-resistant) gram-negative pathogens. These pathogens are a special type of harmful bacteria called gram-negative bacteria that are resistant to a group of powerful antibiotics called carbapenems, including a special antibiotic called meropenem. Simply put, these bacteria have developed defenses that cannot be destroyed by strong antibiotics, making infections caused by these bacteria very difficult to treat.
Zaynich is a combination of two potent antibiotics, didbactam and cefepime (WCK 5222), and was used in this study to treat hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and bloodstream infections (BSI). It is suitable for the treatment of a variety of serious infections including: complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). Approximately 17% of these patients have a concurrent bloodstream infection, compounding the treatment challenge. The overall clinical efficacy of Zaynich in all indications in the trial-of-treatment (TOC) 7-10 days after completion of treatment was 98%, compared to 100% for BSI, HABP/VABP, cIAI and 100% for other 97.3%. . cUTI. Of note, Zaynich also demonstrated high pathogen eradication rates (microbiological therapy), even in difficult-to-treat HABP/VABP (91%) and BSI patients (100%).
Based on this clinical research and case studies of intensive care patients in India and the United States, Dr. Its identified more than 100 critically ill patients suffering from severe, drug-resistant gram-negative infections. His testimony helped save more than one life. The clinical trial, conducted in 15 tertiary care hospitals across the country, included only patients with confirmed carbapenem-resistant (including meropenem-resistant) infections that would have been identified using advanced rapid molecular diagnostic techniques. The pathogens involved were extremely drug-resistant (XDR) gram-negative bacteria, including Acinetobacter, Pseudomonas, Klebsiella and Escherichia coli.
The duration of the treatment is 7-21 days. The study protocol was approved by the Drug Controller General of India (DCGI). The study highlights the potential of Zaynich as a life-saving antibiotic, particularly for carbapenem-resistant infections, with 97% efficacy against multidrug-resistant infections. Currently available treatment options for colistin and polymyxin are very limited due to severe side effects and low efficacy. The importance of these findings is reinforced by the global threat of antimicrobial resistance (AMR), in which the majority of people with the most persistent bacterial infections, unresponsive to standard drugs, remain untreatable.
According to the company, Zaynich targets all Gram-negative pathogens identified as a high priority by the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). The new drug candidate is nearing completion of a multinational Phase III study that will support global registration and marketing authorization. In the United States, a number of phase I studies, including clinical pharmacology studies, have previously been conducted with the combination of zydebactam and cefepime. As the incidence of meropenem-resistant infections is significantly higher in India, II. A phase II trial was conducted as definitive proof of Zaynich's effectiveness.
