BU: Recently, the British, German, and Canadian governments have all announced multi-million dollar grants to support CARB-X’s antimicrobial resistance (AMR) research over the next several years. Who will these investments benefit and why are they so essential?

Kevin Outterson: Antibiotics are life-saving drugs that fight against bacterial infections. They are the safety net of modern medicine and make medical treatments such as dialysis, chemotherapy, c-sections and organ transplants safer. Yet the global pipeline of new antibiotics has become dangerously thin.

CARB-X has a global mission: to accelerate a diverse portfolio of innovative antibacterial products towards clinical development and regulatory approval with funding, expert support and portfolio acceleration tools. Over a million people died from antimicrobial resistance (AMR) in 2019 across the world. This is more deaths than from HIV/AIDs (864,000) and malaria (643,000) that same year!

CARB-X products include new antibiotics, vaccines and diagnostics for patients worldwide. In order to receive funding from CARB-X, all of our product developers must agree to develop Stewardship & Access Plans that identify how a product will be manufactured and distributed for use in low-resource settings. All of the products we invest in — new antibiotics, vaccines and diagnostics — address the most deadly bacteria identified by the WHO and CDC.

The new funding from the United Kingdom, Germany and Canada will be used along with our funding from the United States government, Wellcome Trust and Bill & Melinda Gates Foundation to support CARB-X’s current portfolio in addition to new projects that apply through our funding rounds. CARB-X is a lean operation which means that 95% of funding supports product developers.

BU: Why are countries coming together now to combat antimicrobial resistance? Why the global response?

Kevin Outterson: We often say, “bacteria know no borders.” AMR affects people in all countries and has recently been recognized by G7 governments as a major threat to public health. The latest AMR Progress Report from the World Health Organization and the Global AMR R&D Hub also highlighted the need for additional funding to “replenish a weak clinical pipeline” and recommended commitments “to further financing of public-private partnerships such as CARB-X”. There is also a United Nations General Assembly High-Level Meeting on AMR planned for 2024 that has spurred government response. The recently released Atlantic Declaration between the UK and US governments is a phenomenal example of government leadership addressing AMR through biosecurity strategies.

BU: How will CARB-X partner with each government? What are the priority initiatives?

Kevin Outterson: As a global organization, our teams, partners and product developers are located and operating worldwide. CARB-X pools funding from governments and foundations and funds product developers through a rigorous investment decision process. Representatives from each of our funders serve on our Joint Oversight Board who set overall strategy, scope, budget and key performance indicators for CARB-X. This benefits both our funders and product developers.

CARB-X is in the unique position of having a portfolio view of AMR product development. In other words, we see common issues across product developers, and combine our own expertise with external subject-matter experts to provide product developers with high-quality, tailored support from around the world. This knowledge means that we can leverage funders’ investments to foster the best science around the world. Furthermore, from a product developer standpoint, they receive funding through one, streamlined source, as well as top-notch scientific, regulatory and business expertise.

BU: What populations are currently most at-risk to drug-resistant infections?

Kevin Outterson: Of the 1.27 million deaths in 2019 attributed to AMR and the 4.95 million deaths associated with AMR in The Lancet study, the burden is highest in Low- and Middle-Income Countries (LMICs), where the most vulnerable populations live and access to antibiotics, vaccines and diagnostics is limited. I mentioned earlier the Stewardship & Access Plans which will cover all products within our portfolio, but CARB-X is also supporting the development of products that address AMR in LMICs directly, and in a variety of ways. For example, CARB-X accelerates innovation in India today leads a series of research projects which help address common challenges faced by product developers, and partners with other accelerators to help advise on in-country manufacturing, regulatory and clinical considerations.

BU: Are there any new AMR research projects/breakthroughs that are currently underway?

Kevin Outterson: Help is on the way! Since inception in 2016, CARB-X has funded the development of 92 products. To highlight a few, Bugworks is a company located in India developing a novel class, broad-spectrum antibiotic that targets infections caused by multidrug-resistant Gram-negative bacteria. The new antibiotic is designed to be given intravenously and orally which will allow patients to be treated in and outside hospitals, lowering healthcare costs and infection risks. They began their Phase 1 clinical trial in 2021.

Based in Italy, GSK’s Global Health Vaccine Unit is in Phase 1 clinical trials for a vaccine they’re developing that targets Salmonella enterica. S. enterica can cause invasive nontyphoidal salmonellosis (iNTS) and typhoid fever. iNTS is a major cause of death in sub-Saharan Africa.

Out of Scotland, Proteus has produced a lung imaging platform technology that uses bacteria-specific Smartprobes and fiber-based imaging to produce live visualizations of bacteria and host immune cells deep in the lungs. This technology is currently being evaluated in patients in the verification and validation stage of diagnostic development. It could enable precise diagnosis and prescribing of drugs for patients who are mechanically ventilated and critically unwell.

All of these projects came into the CARB-X portfolio and successfully progressed through development stages and are being tested with patients.

BU: Anything else you would like to add?

Kevin Outterson: We are grateful to the UK and German governments for recommitting to CARB-X and our mission to replenish the global clinical pipeline. We are also thrilled that Canada has committed to join our public-private partnership. Just like COVID-19, AMR can only be curbed when governments, foundations, academia and industry work together. Thanks to the support we receive, the CARB-X model has successfully identified and advanced innovative AMR products across therapeutics, preventatives and diagnostics.

Two diagnostic companies that we supported already have their products on the market in Europe and two more have begun Verification & Validation in humans. Thirteen therapeutic and vaccine projects have begun or completed First-in-Human clinical trials. And we continue to get applications from new organizations! Our third funding round this year received more applications than the first two combined. A significant percentage of these companies had not applied to CARB-X before.