CARB-X continues its acceleration of innovative therapeutics, preventatives and diagnostics against antibiotic-resistant bacteria
(BOSTON: May 19, 2022) – After celebrating its five-year anniversary in 2021, CARB-X (part of Boston University) announces renewed support from the U.S. Department of Health and Human Services (HHS) and Wellcome, a global charitable foundation. The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within HHS, will provide US$20 million initially and up to US$300 million over 10 years to support the existing portfolio and launch new funding rounds.
The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, will provide support in the form of in-kind services through access to a suite of preclinical services for product development. Wellcome will provide up to US$70 million over three years as part of its continued commitment to address the escalating threat of drug-resistant infections. Initial funding of $355 million from both BARDA and Wellcome originally launched CARB-X in 2016, and the new funding announced today builds on the success of this international non-profit partnership.
“We are grateful for the leadership and commitment demonstrated by BARDA and Wellcome in addressing the global challenge of antimicrobial resistant bacteria,” said Kevin Outterson, Executive Director of CARB-X and Professor of Law at Boston University. “We now know that antimicrobial resistance (AMR) kills more people each year than HIV or malaria, and a similar number to TB. AMR is a top-tier global killer. With today’s funding announcements, CARB-X will continue to invest to support early-stage research and development (R&D) for new antibacterial therapies, preventatives, and diagnostics.”
In addition to BARDA, NIAID and Wellcome, other CARB-X funders and partners include the U.K. and German governments (the Global AMR Innovation Fund and the Federal Ministry of Education and Research), and the Bill & Melinda Gates Foundation. Their original agreements end in 2022 and 2023 and are not yet up for renewal.
“Antibiotic-resistant infections not only pose a growing public health crisis but also complicate the response to public health emergencies. We see a wealth of valuable basic AMR research and early discovery stemming from NIAID and other critical organizations around the globe. Alongside our CARB-X global partners, we are helping transform this research into preclinical and clinical candidates that, with potential support from BARDA and other late-stage funders, can be further developed into approved products that can help prevent and treat bacterial infections, and ultimately, save lives,” said Gary Disbrow, PhD, Director of BARDA.
Since its inception, CARB-X has received over US$500 million and invested US$361 million of this non-dilutive funding to support the advancement of 92 innovative projects in 12 countries.
Today, the program is made up of a scientifically diverse portfolio that is focused on detecting and eradicating bacterial infections where resistance is threatening the foundation of modern medicine. The hallmark of the portfolio is a spectrum of innovation that will deliver meaningful products that diagnose, prevent and treat infections caused by antibiotic-resistant bacteria.
All active treatment programs feature a novel class of antibiotics, binding a novel bacterial target, or acting on a new pathway, hence offering the ability to prevent cross-resistance with current anti-bacterial mechanisms.
The program already has accelerated products toward the clinic, with eleven candidates for treatment or prevention having progressed into first-in-human clinical trials and with more expected to begin trials later this year. Four diagnostics have progressed into the validation and verification stage, which primes them for pivotal clinical trials. Two companies formerly supported by CARB-X are now supported by BARDA for advanced R&D to bring their candidates closer to approval.
Erin Duffy, Chief of R&D at CARB-X, has prioritized strengthening and diversifying the pipeline by making strategic portfolio decisions. “We are exploring key questions that unblock the path for new products to emerge. An example is bacteriophage, where we are asking whether treatment or prevention is the best placement for this modality, what syndromes and pathogens are the best targets, what trial designs will best highlight medical value and what performance characteristics are essential. In diagnostics, we have sharpened our focus by asking what products would be most meaningful to our treatment and prevention products to open a path to clinical trial feasibility and to influence market uptake after approval.”
There have been no novel classes of antibiotics approved in the last 20 years (Blaskovich, M.A.T., 2019 The diminished antimicrobial pipeline, Micro. Aust.) The last one, linezolid, was approved in 2000 but its class, oxazolidinone, was discovered in 1978. An additional challenge specific to this area is that once approved, the products needed to treat antibiotic-resistant infections should be used only when necessary, otherwise bacteria develop further resistance. Because current commercial models do not reward antibiotic stewardship, developers often struggle to recoup R&D costs or see a return on investment. This has led many companies to withdraw from the antibacterial space, creating diminished investment in innovation and weak pipelines.
The non-dilutive funding and wrap-around technical, regulatory, and business support that CARB-X provides to companies in early-stage development help to overcome these challenges and ensure there is a pipeline of candidates poised for advanced R&D by late-stage development funders.
“Early-stage research and development for antibiotics was stalled in 2016. Since our first investment in CARB-X, the initiative has successfully fostered innovation in this essential stage of development for antibiotics, vaccines, and diagnostics. We are proud to have been part of CARB-X’s journey to ensure promising products can make it to patients who need them. This additional investment will help CARB-X continue to revitalise the world’s antibacterial pipeline and other interventions to control antimicrobial resistance,” said Dr. Timothy Jinks, Head, Infectious Disease Interventions, Wellcome.
Antibiotic resistance is a rapidly growing and deadly threat to the health of humanity and our global economy. Global Research on AntiMicrobial resistance (GRAM) Project released a report in The Lancet on 20 January 2022 estimating 1.27 million deaths occurred in 2019 due to antibiotic-resistant infections.
“CARB-X’s mission and global public-private partnership is filling a critical gap to help stem the AMR crisis,” said Dr. Robert A. Brown, President of Boston University. “We are grateful for the support of BARDA and Wellcome as researchers accelerate the discovery of new antibiotic classes around the world.”
A public webinar will be held on June 9, 2022 at 09:00am EDT with representatives from CARB-X, BARDA, Wellcome and NIAID to discuss the global health issues of AMR, and how CARB-X and its partners are working together to address them.
Register in advance to attend the public webinar.
The contents of this news release are solely the responsibility of the author and do not necessarily represent the official views of all CARB-X funders.
CARB-X Contact: Robin Berghaus, carbxpr@bu.edu