“Our drug, WCK5222, which is at present undergoing clinical trials in some European nations, was mentioned by the World Health Organisation as a promising antibiotic under research,” said chief scientific officer Mahesh Patel of Wockhardt Research Centre in Aurangabad.
In early August, a couple of days after the tuck, the 50-year-old Nepali woman developed a fever that soon worsened into a lung infection. A few days later, her liver and kidneys too were affected. Sepsis rapidly set in and she was put on ventilator support, with the culprit identified as a gram-negative bacteria called Pseudomonas aeruginosa. Gram negative bacteria are resistant to multiple drugs and in her case, the Pseudomonas A bacteria was resistant to all antibiotics, expect colistin. Three weeks later, it became resistant to colistin too, meaning there was no drug available to treat the patient who had by then been transferred from a local hospital to Medanta Lucknow.
India, where antibiotics are often self-prescribed or by chemists, has been witnessing alarming levels of antibiotic or antimicrobial resistance. The Indian Council for Medical Research (ICMR)’s fifth detailed report on antimicrobial resistance (AMR) trends and patterns showed that many ICU patients no longer benefit from carbapenem, a powerful antibiotic used to treat pneumonia and septicemia.
Resistance level is increasing by 5% to 10% every year for broad-spectrum antimicrobials, mainly due to discriminate use leading to resistance later one. “India has high rates of multi-drug resistance among enterobacterales and gram-negative non-fermenters like Acinetobacter baumanii and Pseudomonas aeruginosa. New treatment options are urgently needed for such multi or extremely drug-resistant pathogens,” said ICMR’s senior scientist Kamini Walia, who coordinates antimicrobial resistance and diagnostics initiatives across the country.
Fortunately for the Nepali national, critical care specialist at Medanta Lucknow Dr Dilip Dubey remembered reading about WCK5222 in research papers and called up Wockhardt. He was told that only families could request for the drug on compassionate grounds and that too after seeking permission from the Drugs Controller General of India (DCGI). The family immediately wrote to the DCGI and got an approval within the next 48 hours, the doctor said.
A 10-day course of WCK5222 was given free of cost to the patient. “Although we gave the medicine for 10 days, she was free of the bacteria by Day 5,” said Dr Dubey. The patient was discharged on September 12, and came in for five follow-up visits to Medanta Lucknow. A couple of weeks back, she got the medical nod to return to Nepal.
The next step is starting clinical trials in India. “For WCK5222, we have special USFDA approvals and plan to start studies in India soon,” said Wockhardt researchers Mahesh Patel and Sachin Bhagwat.
Work on WCK5222 began in 2012 with 130 scientists working on it. A Phase 1 trial of 200 patients was conducted in the US that revealed that the drug is safe for use in humans. The company has received requests from other parts of the world as well as four requests from India. “But we didn’t get enough time to process the paperwork,” he said. The drug has already got 25-30 publications.