India’s ‘blockbuster’ drugs to take on deadly superbugs
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Drug-resistant infections are most prevalent in critical care units
Antibiotics are hailed as medical saviours.
But they are increasingly facing a crafty adversary: bacteria that mutate and adapt and outwit the very drugs designed to defeat them and cure the infections they cause.
These antibiotic-resistant “superbugs” directly caused 1.14 million deaths worldwide in 2021, according to The Lancet, a medical journal. Antibiotics – which are considered to be the first line of defence against severe infections – did not work on most of these cases.
India is among the countries hardest hit by “antimicrobial resistance”. In 2019 alone, antibiotic-resistant infections caused around 300,000 deaths. They alone are responsible for the deaths of nearly 60,000 newborns each year.
But some hope is on the horizon. A number of promising locally-developed new drugs show potential to combat antibiotic-resistant pathogens. They also offer a game-changing solution to preserve last-resort treatments.
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Pseudomonas aeruginosa, a drug-resistant bacteria, is a major concern for doctors
Enmetazobactam, developed by Chennai-based Orchid Pharma, is the first antimicrobial invented in India to be approved by the US Food and Drug Administration (FDA). This injectable drug treats severe conditions like urinary tract infections (UTIs), pneumonia and bloodstream infections by targeting bacteria’s defence mechanisms rather than the bacteria itself.
Bacteria often produce enzymes, like beta-lactamase, to destroy antibiotics. Enmetazobactam binds tightly to those enzymes, neutralising them and allowing the antibiotic to kill the bacteria effectively.
To put it simply, the drug immobilises the bacteria’s “weapon” without triggering resistance easily. This also preserves the effectiveness of other antibiotics, including carbapenems, which are the reliable “last line of defence” drugs.
Trials across 19 countries – the drug has been approved by global regulators – with more than 1,000 patients have shown its effectiveness. “The drug has shown remarkable potency against these bacteria that have evolved over the years. It is administered via intravenous [IV] infusion in hospitals, specifically for critically ill patients, and is not available over the counter,” Dr Maneesh Paul, the lead co-inventor of the drug, told the BBC.
Mumbai-based Wockhardt is testing a new antibiotic, called Zaynich, for severe drug-resistant infections. Developed over 25 years, the drug is currently in Phase-3 trials and expected to launch next year.
Dr Habib Khorakiwala, founder chairman of Wockhardt, has described Zaynich as a “ground-breaking, one-of-its-kind new antibiotic designed to combat all major superbugs”. It was administered on compassionate grounds to 30 critically ill patients in India who were unresponsive to any other antibiotics. Remarkably, all survived. “This would make India proud,” Dr Khorakiwala said.
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Mumbai-based Wockhardt is testing promising new antibiotics that will work on drug-resistant bacteria
Also in Phase-3 testing is Wockhardt’s Nafithromycin, trademarked as MIQNAF, a three-day oral treatment for community-acquired bacterial pneumonia with a 97% success rate. Existing treatments to the disease have resistance as high as 60%. Its trials are set to conclude next year and once it’s approved, the company says it could be launched commercially by late next year.
A 30-member Bengaluru-based biopharma firm Bugworks Research has partnered with Geneva-based non-profit Global Antibiotic Research and Development Partnership, or GARDP, to develop a new class of antibiotics for treating serious drug-resistant infections. Currently in early Phase-1 trials, the drug is five-to-eight years from market readiness.
“Antibiotics are becoming less effective, but big money is in drugs for cancer, diabetes and other conditions, not antibiotics,” Anand Anandkumar, CEO of Bugworks, told the BBC.
