Antimicrobial resistance (AMR) is a massive ongoing challenge in need of new solutions, but the lack of return on investment for antibiotic drug development is keeping new drugs at bay. In the past few years, only a handful of pharma companies have kept antibiotics in their pipelines, and without the market’s high incentives, those that are tackling AMR are teaming up with the federal government and nonprofits to help fund their efforts.
From 2017 to 2022, only a dozen new antibiotics were approved by the FDA, according to the World Health Organization. Without much in the industry’s development pipeline, the gap between R&D and unmet need is considered a “dead zone,” said Erin Duffy, chief of R&D at biopharmaceutical accelerator CARB-X.
“They can’t make any money,” Duffy said of pharmas working on antibiotics.
CARB-X — Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator — is a recent innovation in the industry’s AMR equation. Created in 2016, CARB-X provides funding to companies working on AMR-related diagnostics, therapeutics and vaccines. Its pipeline, focused on the “greatest bacterial threats to humans,” includes work with GSK and Novo Nordisk’s philanthropic arm. With financial backing from numerous organizations and government sources, including the Biomedical Advanced Research and Development Authority (BARDA), CARB-X recently announced its 2024 funding round to fill R&D gaps, asking for applicants focused on where AMR burden is the highest.
“With many more deaths than was previously really understood, this is a growing problem because bacteria and fungi are living organisms that are continually evolving."
Emily Wheeler
Director, infectious disease policy, Biotechnology Innovation Organization
But because bacteria can become resistant to antibiotics and they need to be used sparingly, it remains a tough sell for pharma.
“We need these antibiotics on the shelf, but we need to be very careful about when they're used,” said Emily Wheeler, director of infectious disease policy at Biotechnology Innovation Organization. “That's a good thing for public health, but it makes a really challenging business model in a traditional market dynamic that is based in the drug space on volume of use.”
However, some new antimicrobial products are making their way through pharma’s pipeline. In February, GSK announced positive results from a phase 3 trial testing a new antibiotic to treat gonorrhea, which has recently become one of the most common superbugs and is the second most common sexually transmitted infection in the U.S. The drug could be on the market by 2025, CNBC reported. The pharma giant also snagged fast track designation by the FDA for its experimental gonorrhea vaccine candidate, NgG, last year.
CARB-X has partnered with GSK on a few of its antimicrobial candidates, and providing funding for a phase 1 small molecule drug aimed at preventing UTIs, plus vaccine candidates for streptococcus and Salmonella enterica.
An ever-growing threat
The need for more collaboration between the pharma industry and outside funding sources comes as recent studies on the impact of AMR reveal the problem is much bigger than once thought. According to WHO, an estimated 1.27 million deaths globally in 2019 were directly caused by bacterial AMR. Another recent study published in The Lancet found there were an estimated 250,000 deaths in Africa directly attributed to it and another 1.05 million deaths associated with bacterial AMR in 2019. In fact, AMR killed more people in Africa in 2022 than either HIV or malaria.
“With many more deaths than was previously really understood, this is a growing problem because bacteria and fungi are living organisms that are continually evolving … [and] want to fight … the drugs used to treat them,” Wheeler said.
Along with incentives supporting AMR R&D such asCARB-X, the PASTEUR Act has been introduced in Congress multiple times and would include $6 billion in funding for AMR drugs. More than 250 organizations support the bill, according to Wheeler. But so far, the bill has been tied up in committees and has yet to pass. For pharma, collaboration will be key to solving the AMR threat.
“Antimicrobial resistance is a threat that impacts everyone, everywhere,” Wheeler said. “And it truly is a really complex problem that needs an all-hands-on-deck approach to combat it.”
Duffy agrees that the responsibility of addressing AMR is a shared one.
“It's a multi-stakeholder responsibility, [and] certainly governments are part of that because they have to understand it's a matter of national security,” Duffy said. “Consumers, doctors, and of course the private market, all these people need to take a role in it.”
