World War 1 resulted in the death of about 10 million soldiers. About half of them died not due to battle injuries, but from infections caused by wounds or injuries. During World War 2, things changed. If the death rate from bacterial pneumonia in WW1 was 18 per cent, in WW2 it was less than one per cent. The reason? Penicillin.
The first antibiotic agent, penicillin, discovered almost a century ago, paved the way for saving millions of lives. Yet, ever since, only a few novel classes of antibiotics have been found. On top of it, bacterial Antimicrobial Resistance (AMR), the phenomenon of bacteria developing increased resistance to existing classes of drugs, has been concerning the medical world.
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A 2022 study published by Lancet termed bacterial AMR as ‘one of the leading public health threats of the 21st century.’ The study estimated 4.95 million deaths associated with bacterial AMR in 2019.
Cut to India and about two million deaths are projected to occur in the country by 2050 due to AMR.
Bengaluru-based Bugworks Research is trying to develop a novel class of broad-spectrum antibiotics to fight some of the most drug-resistant superbugs causing infection and a large number of deaths across the globe.
It is about to enter its phase-1 clinical trial next month in Adelaide, Australia.
The writing on the wall
Anand Anandkumar, Balasubramanian V., Shahul Hameed, and Santanu Datta founded Bugworks nine years ago.
“We saw the writing on the wall. Antimicrobial resistance was increasing, but big pharmaceutical companies were leaving the space because it was not a lucrative space,” Dr. Anandkumar says.
“Antibiotics don’t have a business volume like the medicines for diabetes or blood pressure. On top of it, the science is incredibly hard to understand,” he adds.
Then what prompted Bugworks to attempt it? Dr. Anandkumar calls it contextual innovation.
Best solution for the worst enemy
“India is one of the places with the worst problem of superbugs. Why not find the best solutions from where you have the worst enemy?”
The country has been facing a rising problem of mortality owing to AMR with patients often catching serious infections from hospitals and community settings.
Dr. Anandkumar explains the graveness of the problem with the example of infections in cancer patients.
“You can have the best cancer therapy, but the patient can pick up an infection post chemotherapy and die. One-third of the people who die after cancer therapy are dying due to infections they picked up because the body’s immune system is weakened by chemotherapy and radiotherapy.”
In India, several factors contribute to the problem.
Overuse and misuse of antibiotics is a major reason behind bacteria developing resistance to drugs. Experts have cited poor public health infrastructure, a high density of population and high disease burden, unregulated sales of drugs, lack of personal hygiene, poor practices in hospitals, and improper disposal of waste by antibiotic manufacturers resulting in it reaching the water streams and making its way through the entire food supply chain resulting in a rapid rise in resistant infections.
Around the time the Bugworks team was pondering setting up the company, AstraZeneca closed down its infectious disease group in Bengaluru. A large part of the Bugworks team is former AstraZeneca employees. The company collaborated with St John’s Hospital and Narayana Hrudayalaya to test its assets against the tough super bugs.
“My counterparts in the Bay Area, Boston, and London were testing their assets on multi-drug resistant pathogens that are not as harsh as what we see in our backyard. If you have a tough problem in our country, use that to your advantage and come up with a new contextual solution,” Dr. Anandkumar says.
Today the company has an antibiotic as well as an oncology platform. If successful, the antibiotic drug would be available as an IV drug for serious hospital infections. It would also have an oral step-down variant. Meanwhile, the immuno-oncology molecule the company is developing is expected to enter clinical trials next year.
According to Dr. Anandkumar, the antibiotic drug would be effective not just against serious infections in hospitals and communities, but would also help to fight bioterrorism pathogens.
“Some governments are keen on working with us to help them with a bio-defense strategy,” he says.
A go-to-globe strategy
Most of the money raised in terms of funding and grants by Bugworks has been from outside India. The bulk of the funding came through grants from the United States government. The company also recently signed a term sheet with the Global Antibiotic Research and Development Partnership (GARDP) which would provide it with up to $20 million if the compound makes it through the phase-1 trial.
During its early days, the company also received funding from the Department of Biotechnology, early-stage venture capital firm 3one4 Capital, and angel investors including Kiran Mazumdar Shaw and Featherlite group among others.
“It is good to have some support from India, but more than 90 per cent of our fundraise happened outside India.”
If successful, the antibiotic would be launched across the globe. GARDP would obtain manufacturing and commercialization rights in more than 140 countries including low and middle-income countries. Bugworks would retain the license for Europe, the US, China, Japan, Australia and India.
“India is the toughest AMR region. And the product came out of India. So, we want to make sure this product makes it to India with the highest priority,” Dr. Anandkumar says.
“We have the largest problem with infection, diabetes, or oncology. Yet we wait for someone else to innovate and then do biosimilars. Biosimilars are not bad; They allow us to get cheaper versions of a costly drug. But when are we going to make our own innovation, solve our own problems, and offer solutions to the universe from here? That’s what we are trying to do. It’s not go-to-market, it is ‘go-to-globe.’