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The Novo Nordisk Foundation is committing up to $25 million to support the early-stage development of innovative tools to prevent, diagnose and treat the most dangerous drug-resistant bacterial infections. The three-year grant will go to the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), the leading global non-profit public-private partnership in this space.
Antimicrobials, including antibiotics, are the world’s primary defence against infections. But when the bacteria, viruses, fungi or parasites that cause those infections mutate and become resistant to existing treatments, simple infections can lead to severe illness or death.
Antimicrobial resistance (AMR) threatens to unravel societies and the global economic system by increasing the risks of performing routine medical procedures such as caesarean sections, hip replacements and chemotherapy, impairing our food chain, and diminishing productivity. The most comprehensive assessment of the burden of AMR to date found that drug-resistant bacterial infections alone caused an estimated 3,500 deaths every day in 2019, a number on the rise and already higher than both HIV/AIDS and malaria. According to the World Bank, in a high AMR-impact scenario, the world would lose 3.8 percent of its annual GDP by 2050, with an annual shortfall of $3.4 trillion by 2030.
A key part of the solution is the development of new vaccines, diagnostic tools, antibiotics, and other innovative interventions that can help prevent these infections, diagnose them quickly and accurately, and treat them effectively. Yet, most major pharmaceutical companies have exited the market and those left in the early development space tend to be academic spinouts and small companies in need of grants and guidance.
CARB-X, a global non-profit partnership funded by four G7 governments and three of the world’s biggest foundations, is a leading provider of support to these product developers. The partnership, therefore, plays a crucial role in moving promising ideas for cutting-edge antibacterial products from basic research to clinical development and through Phase 1 clinical trials. Since 2016, CARB-X has funded 93 projects in 12 countries. Nineteen projects have advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and two diagnostic products have reached the market.
“Like CARB-X, the Novo Nordisk Foundation is committed to driving innovation in the fight against drug-resistant infections,” says Peter Lawætz Andersen, Senior Vice President in Infectious Disease at the Foundation. “By partnering, we can help ensure that the best research gets translated into effective, scalable and affordable medical interventions that can help end this growing pandemic.”
“CARB-X is grateful for this generous contribution from the Novo Nordisk Foundation, a key ally in CARB-X’s mission,” says Kevin Outterson, Executive Director of CARB-X and Austin B. Fletcher Professor of Law at Boston University. “This new funding is a testament to our shared commitment to supporting the pioneering efforts of antibacterial product developers, mainly university spinoffs and small biotech companies, in advancing much-needed innovation to prevent, diagnose and treat the most dangerous drug-resistant bacterial infections.”
Battling a Broken Market
Despite the importance of antibiotics in modern medicine, only two new classes (types) have reached the market since 1962 and there are very few in clinical development. According to the World Health Organization, “the clinical pipeline and the recently approved antibacterial agents are insufficient to tackle the challenge of increasing emergence and the spread of AMR.”
Private investments in innovative antibiotics are poor partly because doctors use them only when older and cheaper drugs fail. This is important to prolong their effectiveness, but it also limits their sales. This broken market has created a huge funding gap in antibacterial product development. A report for the European Commission has recently estimated that an additional global investment of USD 250 to 400 million from public and philanthropic sources is needed every year for the R&D of products that counter drug resistance, and that this investment should focus in the early phase of development, which is where CARB-X operates.
Novo Holdings – the Foundation’s wholly owned subsidiary – established the REPAIR (Replenishing and Enabling the Pipeline for Anti-Infective Resistance) Impact Fund in 2018 to address this early-stage funding gap. While continuing to support the existing portfolio, REPAIR has paused new investments due to the challenging market conditions, with the Foundation now supporting the critical early-stage pipeline via the philanthropic grant to CARB-X.
Developing Cutting-Edge Products
The grant is also part of a broader commitment from the Foundation and Novo Holdings to fight drug resistance through the development of innovative products. The organisations are engaged in a range of activities from early development to advocating for payment models that can help rejuvenate the market for antimicrobials. The Foundation is also funding a major new initiative – the Novo Nordisk Foundation Initiative for Vaccines and Immunity – that will reduce the use of antibiotics and thus the spread of AMR by developing vaccines against respiratory infections.
With this grant, the Novo Nordisk Foundation joins major governments and foundations in supporting the work of CARB-X. Efforts are focused on the most dangerous bacteria which have been prioritised by the World Health Organization and the United States Centers for Disease Control and Prevention (CDC), the syndromes with the greatest morbidity and mortality across the world, and the performance characteristics that clinicians and patients need the most. Beyond non-dilutive funding, CARB-X provides grantees with scientific, clinical, regulatory, and business development guidance and access to tools that aim to accelerate product development.