Italian Government Gives $21 Million to BU-Led Effort to Develop New Antibiotics, Vaccines, Diagnostics
Among CARB-X’s priorities is the development of products that can prevent disease caused by the pathogens causing the greatest mortality globally, including Escherichia coli. Illustration by Artur Plawgo/iStock
Italian Government Gives $21 Million to BU-Led Effort to Develop New Antibiotics, Vaccines, Diagnostics
Nonprofit research and product accelerator CARB-X will use funding in fight against antimicrobial resistance
A Boston University–led nonprofit that’s taking on the growing threat of antibiotic-resistant bacteria has just received a significant injection of new funding—from the Italian government.
Italy has awarded CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) $21 million to help drive its work to advance new antibiotics, vaccines, and rapid diagnostics for infections that don’t respond to existing treatments. CARB-X is based at the BU School of Law.
The three-year grant was announced at the G7 Joint Finance and Health Ministers’ Meeting, which was held in Ancona, Italy, earlier this month. Speaking at a meeting press conference, Italy’s health minister Orazio Schillaci said antimicrobial resistance (AMR) was “a silent enemy that hides in the shadows and threatens us, it risks nullifying the many advances made by modern medicine and it is a real emergency. It is the new pandemic.” According to the World Health Organization, AMR is associated with nearly five million global deaths annually.
CARB-X already receives backing from the governments of the US, Germany, United Kingdom, and Canada, as well as the global charitable trust Wellcome, the Bill & Melinda Gates Foundation, and the Novo Nordisk Foundation. The nonprofit accelerator uses its funding to support promising research and product development projects around the world.
Schillaci said that the $21 million commitment showed “Italy is at the forefront together with the other G7 governments in the experimentation and identification of new solutions to manage the crisis of antimicrobial resistance.”
Since its launch in 2016, CARB-X has given out close to $500 million in funding, advancing more than 100 projects in 13 countries.
“We are profoundly grateful to the Italian government for their generous support,” says Kevin Outterson, CARB-X’s executive director and Austin B. Fletcher Professor of Law at BU School of Law. He presented on the current status of the fight against antimicrobial resistance at the G7 event. “Italy’s investment is a powerful addition to the support we receive from our global consortium of funders, including other G7 governments and leading global health foundations. This collective effort underscores the critical importance of international collaboration in the fight against AMR. Together, we are driving innovation and ensuring that the most promising research can be translated into lifesaving treatments for patients worldwide.”
The Brink spoke with Outterson about the Italian government’s pledge and some of the promising products in CARB-X’s portfolio.
Q&A
with Kevin Outterson
The Brink: What prompted the Italian government to make this investment now?
Outterson: The Italian government selected AMR as one of the priority topics for its presidency of the G7. This is why, in May, G7 finance ministers agreed to discuss ways to promote research into new antimicrobials and, in June, G7 leaders confirmed [in a statement] that they will “implement push and pull incentives, support public-private partnerships, and explore innovative instruments to accelerate research and development on new antimicrobials, their alternatives, and diagnostics.” New funding to CARB-X—which is a leading global example of a “push” incentive—represents an impactful way to implement these commitments. It is a natural time and place for this work.
The Brink: What might this $21 million allow CARB-X to do that it couldn’t do before, or what new projects could the grant help support?
Outterson: CARB-X pools the funding from governments and foundations and then uses it to execute our portfolio strategy to restore the antibacterial pipeline. The funding from the Italian government will help support a much-needed variety of antibacterial products rather than a particular type of project. CARB-X is committed to supporting research and development (R&D) projects with the goal of delivering into human clinical trials high-value products to prevent, diagnose, and treat bacterial infections driving the greatest global burden of disease.
The grant from Italy will augment CARB-X efforts to ensure that there are enough strong projects progressing through the pipeline so that some make it through the scientific, clinical, and regulatory challenges to become these high-value products. The latest funding round from CARB-X is seeking projects addressing the biggest gaps identified by a global panel of infectious disease experts, including innovative antibiotics with a resistance advantage to treat infections caused by Gram-negative pathogens, which are among the top six pathogens driving the greatest morbidity and mortality globally; novel products to prevent invasive disease caused by Staphylococcus aureus or Escherichia coli, also among the top six pathogens; rapid diagnostics that can work on small blood volumes to identify pathogens causing neonatal sepsis and recommend treatments to prevent death; and validation of novel sample types to accurately diagnose lower respiratory tract infections.
The Brink: You recently spoke at the G7 Joint Finance and Health Ministers’ Meeting: What was your main message?
Outterson: I was invited by the Italian government to deliver the keynote address. I presented the latest evidence on the status of the global antibacterial pipeline and the projected burden of drug-resistant bacterial infections at current funding levels. The presentation showcased a simulation exercise illustrating the potential impact of multiple investment scenarios on future antibiotic approvals and key health and economic indicators, including the estimated lives saved under different funding scenarios. The presentation underscored the inadequacy of the clinical pipeline to address the threat of drug-resistant infections and highlighted the need for urgent action by governments around the world. Replenishing the antibacterial drug development pipeline requires innovative support for early research.
The Brink: Why is it so important for the fight against AMR to be an international effort?
Bacteria know no borders. Every day, bacteria are evolving and becoming more resistant to antibiotics on the market. When an antibiotic is overused or misused, it increases the likelihood that bacteria find ways to render it ineffective, no matter where you are in the world. Because antibiotics are commonly used across the globe for human and animal health, the fight against resistance requires a collaborative, transdisciplinary approach. We also need research from all corners of the world, all hands on deck, to discover and develop novel antibiotics with unique mechanisms of action to treat infections and address resistance. When antibiotics attack bacteria in a way the bacteria haven’t experienced before, it will take time for the bacteria to respond.
The burden of untreatable bacterial infections is particularly high in low- and middle-income countries, requiring a need for innovative products to be accessible and affordable worldwide. Resistance will only grow stronger if the needs of these countries are not addressed. The fight against AMR is a test of our society and our ability to take care of our most vulnerable communities.
The Brink: The United Nations’ member states recently highlighted CARB-X’s work in a political declaration on AMR. What was the significance of that statement and how might it help advance your work?
The first UN high-level meeting on AMR was held in 2016, the year when CARB-X was founded. Now, eight years later, UN member states have expressly acknowledged the benefit of public-private partnerships such as CARB-X, while renewing their commitment to incentivizing this work. The direct mention of CARB-X, paired with the commitment to further explore incentives, validates our global role as a much-needed accelerator for life-saving antibacterial products and enhances our global visibility, which hopefully leads to increased funding and new partnerships.
CARB-X has been called out by name in official communiques from the UN General Assembly, the G7, and the G20. We’ve come a long way from 2016.
The Brink: Is there a CARB-X project that you’re particularly excited about at the moment?
Are you asking which of our children is the best? This is an exciting time for the CARB-X portfolio, as a whole. In eight years, we’ve supported 104 R&D projects in 13 countries. We are now seeing these projects make significant progress: 18 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. Plus, at least nine product developers with active R&D projects have already secured advanced development partnerships to support their clinical development after leaving the CARB-X portfolio.
Bringing new antibiotics to market takes time, but of the highly innovative new therapeutics for the most dangerous bacterial infections in Phase 1 clinical trials worldwide, 50 percent of them came through CARB-X.
It is important to approach the portfolio holistically. One exciting product will not fix the issue of antibiotic resistance. We need a continuous, robust supply of innovative preventatives, therapeutics, and diagnostics to keep bacteria at bay and reduce the number of deaths attributable to antimicrobial resistance worldwide.
Comments & Discussion
Boston University moderates comments to facilitate an informed, substantive, civil conversation. Abusive, profane, self-promotional, misleading, incoherent or off-topic comments will be rejected. Moderators are staffed during regular business hours (EST) and can only accept comments written in English. Statistics or facts must include a citation or a link to the citation.