Pandemic underscores the critical need to be prepared for global health crises
(BOSTON) – CARB-X made significant progress in its fourth year of operation, with a record number of awards and list of solid achievements, ramping up its efforts to accelerate innovation to combat the spread of antibiotic resistant bacteria. During the fiscal year which ended July 31, 2020, CARB-X granted $127.5 million to product developers and issued 23 new awards to support the early development of novel antibacterial products – the most new awards and funding in any single year since CARB-X was launched in 2016.
The achievement is just one of the highlights in CARB-X’s 2019-2020 Annual Report published today. CARB-X supports the world’s largest and most diverse pipeline of innovative antibiotics and other therapeutics, vaccines and other prevention approaches, and rapid diagnostics to tackle antibiotic-resistant bacteria. In addition to a record number of awards, CARB-X also had a number of firsts during the fiscal year.
- 1st project funded by CARB-X to achieve regulatory approval, a rapid diagnostic developed by T2 Biosystems which is also the 1st of the CARB-X portfolio to receive a US government New Technology Add-on Payment approval recognizing it as a breakthrough technology in the fight against AMR
- 1st CRISPR/phage project in the portfolio, under development by Eligo Bioscience
- 1st projects in Australia, Spain and Germany to be funded by CARB-X, expanding the global reach of the portfolio to 10 countries around the world
- 1st project in the portfolio, under development by Peptilogics, to achieve Orphan Drug Designation from the US Food and Drug Authority (FDA).
“CARB-X has made remarkable progress in supporting the development of innovative products to address the most serious life-threatening antibiotic-resistant bacteria,” said Kevin Outterson, Executive Director of CARB-X, a non-profit global partnership led by Boston University. “We have chosen the most outstanding products in development from amongst more than 1100 applications. The portfolio of products we support represents the future of antibacterial development.”
At year end, CARB-X was progressing 45 active projects in the portfolio, including 19 new classes of antibiotics, vaccines, microbiome projects and other novel approaches. Another 7 projects had successfully graduated from the portfolio, most of which are progressing in clinical development.
Since the partnership launched in 2016, CARB-X has invested $252.7 million and provided expert support to 70 projects, with the potential of additional funding if project milestones are met. Now in its fifth year of operation, CARB-X continues to announce new awards for projects and review applications received in 2019 funding rounds.
“The COVID-19 pandemic underscores the critical importance of being prepared for global health threats, as well as the tragic consequences of being caught flat-footed,” Outterson said. “As we look to the future and track the rise of drug-resistant bacteria, we know that more investment and better financial incentives are needed to accelerate and sustain antibacterial innovation. We are working with our funding partners and global collaborators to find solutions to address the drug-resistance crisis today, and for the future.”
New approaches urgently needed to win the race against bacterial drug-resistance
In the last six decades, only one new class of antibiotics has been approved to address drug-resistant Gram-negative bacteria. During the same period, bacteria have steadily developed new ways to resist the effects of antibiotics.
CARB-X funds only innovative projects that target the most serious drug-resistant bacteria on the CDC’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list. These include carbapenem-resistant Acinetobacter, Enterobacteriaceae, drug-resistant Neisseria gonorrhoeae, multidrug-resistant Pseudomonas aeruginosa, Methicillin-resistant Staphylococcus aureus (MRSA) and many other deadly bugs.
CARB-X is investing up to $480 million in non-dilutive funding between 2016-22 to support the early development of new therapeutics, preventatives and rapid diagnostics. Product development is a long and costly process. CARB-X funding covers between 80 and 90 percent of project costs depending on the development phase of the project. The goal is to support therapeutic and prevention projects from the early phases of development through Phase 1 and from feasibility through to verification/validation stages for diagnostics to enable them to attract additional private or public support for further clinical development and regulatory approval for use in patients. The CARB-X pipeline will continuously evolve, as projects progress and others fail for a variety of reasons.
This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from Wellcome Trust and Germany’s Federal Ministry of Education and Research (BMBF), UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill & Melinda Gates Foundation. The contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Office of the Assistant Secretary for Preparedness and Response, or other CARB-X funders.
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services; the Wellcome Trust, a global charity based in the UK working to improve health globally; Germany’s Federal Ministry of Education and Research (BMBF); the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF); the Bill & Melinda Gates Foundation, with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). CARB-X is investing up to $480 million from 2016-2022 to support innovative antibiotics and other therapeutics, vaccines and other prevention approaches, and rapid diagnostics. CARB-X supports the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X is headquartered at Boston University School of Law. carb-x.org/. Follow us on Twitter @CARB_X.