“Our drug, WCK5222, which is currently in clinical trials in several European countries, has been mentioned by the World Health Organization as a promising antibiotic under investigation,” said the director. Mahesh Patel’s science Wockhardt Research Center in Aurangabad.
In early August, a few days after being wrapped, the 50-year-old Nepali woman developed a fever and quickly developed a lung infection. A few days later, her liver and kidneys were also affected. The sepsis progressed rapidly and she was put on ventilator support, with the culprit identified as a gram-negative bacteria known as Pseudomonas aeruginosa. Gram-negative bacteria are resistant to many drugs, and in her case, Pseudomonas A bacteria were resistant to all antibiotics, expect colistin. Three weeks later, it also became resistant to colistin, meaning there was no drug to treat the patient who was then transferred from a local hospital to Medanta Lucknow.
India, where antibiotics are often self-prescribed or by chemists, has been witnessing an alarming rate of antibiotic or microbial resistance. The Indian Council of Medical Research (ICMR)’s fifth detailed report on antibiotic resistance (AMR) trends and patterns found that many ICU patients no longer benefit from carbapenem, a potent antibiotic. Used to treat pneumonia and sepsis.
Resistance is increasing by 5% to 10% per year to broad-spectrum antibiotics, mainly because discriminatory use leads to later resistance. “India has a high rate of multidrug resistance between enteric bacteria and non-fermentative gram-negative bacteria such as Acinetobacter baumanii and Pseudomonas aeruginosa. ICMR senior scientist, Kamini Walia, who coordinates diagnostics and drug resistance initiatives nationwide.
Fortunately for the critical care specialist, the Nepalese nation at Medanta Lucknow Dr Dilip Dubey remember reading about WCK5222 in research papers and calling Wockhardt. He was told that only his family could claim the drug on compassionate grounds and that too after getting permission from India’s General Control of Drugs (DCGI). The family immediately wrote to DCGI and was approved within the next 48 hours, the doctor said.
A 10-day course of WCK5222 is given to patients free of charge. Dr. Dubey said: “Although we had been on medication for 10 days, she was bacteria-free on day 5. The patient was discharged on September 12 and went to Medanta Lucknow for five follow-up visits. A few weeks ago, she received medical permission to return to Nepal.
The next step is to start clinical trials in India. Wockhardt researchers Mahesh Patel said: “For WCK5222, we have special USFDA approvals and plan to start studies in India soon. Sachin Bhagwat.
Work on WCK5222 started in 2012 with 130 scientists working on it. A phase 1 trial of 200 patients that was conducted in the US showed that the drug is safe to use in humans. The company has received inquiries from other parts of the world as well as four from India. “But we don’t have enough time to process the paperwork,” he said. The drug has 25-30 publications.
