A new report calls attention to some of the progress that's been made over the past year to incentivize antibiotic development while emphasizing how much more work there is to be done.
The report, published this week by the World Health Organization in partnership with the Global Antimicrobial Resistance Research & Development (R&D) Hub, notes that since 2017, public and philanthropic investments in antibiotic R&D have reached $13.75 billion, led by contributions from G7 countries and the European Union (EU).
The financial support has flowed to a range of initiatives that aim to boost early-stage antibiotic development (push incentives) and provide a sustainable return on investment for drug companies that bring new antibiotics to market (pull incentives).
Among the push and pull incentives that have been advanced over the past year are the United Kingdom's subscription model for antibiotics—now fully implemented—and a new pilot project in Canada to secure access to new antibiotics.
Other highlighted efforts include resubmission of the PASTEUR Act, which would create a subscription-style antibiotic payment model in the United States, to Congress and new pledges of financial support from several countries and philanthropic groups for CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) and the Global Antibiotic Research & Development Partnership (GARDP).
The report also notes that on June 14, all G7 countries and the EU reiterated their commitments to implementing push and pull incentives, supporting public-private partnerships, and exploring innovative strategies to accelerate R&D on new antibiotics, alternative treatments, and diagnostics.
More pull incentives needed
The highlighted accomplishments are part of a global effort to bolster the weak pipeline for new antibiotics, which WHO officials and other experts say is insufficient to address current and future needs. According to the WHO's most recent analysis, only 32 new antibiotics are in clinical development that target the priority bacterial pathogens that present the greatest threat to public health. Of those candidates, only 12 are considered innovative.
The aim of these efforts is to address the unique financial challenges of developing new antibiotics, which do not provide enough financial return to cover the costs of R&D, registration, manufacturing, and distribution costs. These challenges have led many large pharmaceutical companies to abandon antibiotic development altogether, leaving the space to smaller companies that often struggle to survive.
Push incentives from groups such as CARB-X aim to boost antibiotic R&D by providing a "crucial lifeline" to promising early-stage candidates that need funding to get into clinical trials. Pull incentives, like the one created under the UK subscription model, aim to provide a guaranteed return on investment for new antibiotics and incentivize companies to keep developing new antibiotics.
While the report applauds the progress that's been made in efforts to address the weak antibiotic pipeline, it concludes that more needs to be done and urges more countries to adopt policies that reward innovation and provide predictable financing for new antibiotics.
"More widespread adoption of policies rewarding successful R&D programs through pull incentives or other innovative financing mechanisms are particularly necessary," the report states. "Such mechanisms would contribute to restoring market health, sustaining the development of novel antibacterials, and stimulating innovation, resulting in benefits to health, productivity, and economic growth."
The report calls on G7 countries to strengthen their commitments to offer pull incentives and other innovative financing mechanisms. It also urges governments to prioritize efforts to ensure equitable access to new antibiotics, particularly in the low- and middle-income countries where deaths associated with lack of access to antibiotics surpass those caused by AMR.
"Ensuring a sustainable and equitable supply of both existing and novel antibacterials to meet global public health needs is crucial for securing a resilient, safe, and economically productive future," the WHO said.
AMR Action Fund invests in new antibiotic candidate
In related news, Chinese drugmaker TenNor Therapeutics announced today that it has received more the $42 million in private investment to support development of a novel antibiotic targeting Heliobacter pylori infections.
The antibiotic, rifasutenizol, is currently in phase 3 clinical trials in China and has received Qualified Infectious Disease Product and Fast Track designations from the US Food and Drug Administration. It would be the first new drug developed specifically for H pylori infections in more than 30 years.
Ensuring a sustainable and equitable supply of both existing and novel antibacterials to meet global public health needs is crucial for securing a resilient, safe, and economically productive future.
The funding includes money from the AMR Action Fund, which was highlighted in the WHO report for its efforts to accelerate the development of traditional and non-traditional antibiotics and diagnostics. Backed by some of the world's largest pharmaceutical companies, the AMR Action Fund was launched in 2020 with the aim of investing $1 billion to bring two to four new antibiotics and antifungals to the market by 2030.
"The global burden of drug-resistant bacterial infections is staggering and only getting worse, with recent data in The Lancet indicating that nearly 40 million people will die from antimicrobial resistance by 2050," AMR Action Fund CEO Henry Skinner, PhD, said in a company press release. "We are pleased to support the team at TenNor as they advance the development of novel antibiotics that could save the lives of patients around the world and significantly reduce the suffering associated with these intractable infections."
