Revitalizing preparedness by accelerating the development
of innovative technologies against drug-resistant infections.
Modern medicine, as we know it, has been made possible by the advent of antibacterials. Health outcomes in the clinic as well as in the community during emergencies or outbreaks rely on effective treatments. Recognizing the challenges facing product development in the antibacterial space and the global threat of antimicrobial resistance, the Antibacterials Program removes barriers to antibacterial drug development through public-private partnerships that provide non-dilutive funding and subject matter expertise.
Our goal is to provide clinicians with therapeutics to prevent and treat biological threat agent infections, antibiotic-resistant secondary infections, and hospital-associated and community-acquired infections.
In 2014, the United States Government released the National Strategy for Combating Antimicrobial Resistant Bacteria. A component of the National Strategy was to establish a “biopharmaceutical incubator” for combating antibiotic-resistant bacteria, a novel concept proposed by BARDA, to revitalize the pipeline of product developers focused on pre-clinical and Investigational New Drug (IND)-enabling research and development. The proposed concept was designed to provide wrap-around services and early development activities that would help progress candidate therapeutic and vaccine products from the hit-to-lead stage through Phase 1 development, and support diagnostics products through early development. In 2016, BARDA, in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) and Wellcome, launched the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) with the mission to “accelerate a diverse portfolio of innovative antibacterial products towards clinical development and regulatory approval with funding, expert support, and cross-project initiatives.” Through CARB-X, BARDA is revitalizing the pipeline of early-stage antimicrobial resistance (AMR) candidates from which the U.S. government or international advanced development programs may select for future funding.
Based out of Boston University, CARB-X now represents the world’s most diverse pre-clinical and early development pipeline of antibiotics and other therapeutics, diagnostics, and preventatives, including microbiome and vaccine candidates. CARB-X continues to diversify their portfolio through contributions from Germany’s Federal Ministry of Education and Research, the UK Government’s Global Antimicrobial Resistance Innovation Fund, and the Bill & Melinda Gates Foundation. They also provide support to projects through their Global Accelerator Network and subject matter experts, many of whom have held senior positions at the US Food & Drug Administration, emerging biotechnology companies, global pharmaceutical companies and academia. This international partnership oversees a unified investment strategy that identifies and fills gaps in critically needed antibiotics and other life-saving products to combat the most dangerous drug-resistant bacteria. In its first five years, CARB-X invested more than $360 million in 92 projects in 12 countries around the world. As of June 2021, CARB-X has supported many successful candidates, including 9 products in first-in-human studies. Two companies have gone on to receive BARDA advanced research and development funding following the conclusion of their CARB-X contract.
Drug candidates demonstrating substantial improvements over existing antimicrobial products are important to the Antibacterials Program. Examples include first-in-class compounds with novel mechanisms of action as well as non-traditional modalities and compounds (e.g. bacteriophage, host-directed immunotherapeutics, etc.).
Priority is given to candidates that address pathogen and indication gaps in our portfolio, have the potential to address an unmet medical need, and/or could target a biothreat pathogen.
Our focus is on developing innovative drugs that treat drug-resistant bacterial infections, with an emphasis on new classes of antibacterials with novel mechanisms of action. Antibacterials within existing classes must demonstrate a significantly meaningful improvement over marketed products – for example, a broader spectrum of activity or reduced toxicity.
We are supporting the development of drugs for the post-exposure prophylaxis and treatment of biothreat pathogens. We are interested in antibacterial candidates with activity against one or more of the following biothreat agents: Bacillus anthracis, multidrug-resistant Bacillus anthracis, Yersinia pestis, Francisella tularensis, Burkholderia mallei, and Burkholderia pseudomallei.
Recognizing financial and development challenges persist following product approval, we support the late-stage development and post-marketing requirements of products for post-exposure prophylaxis and treatment of pathogens. Development activities can include: post-marketing commitments, label expansion studies, and studies in underserved patient populations like pediatrics [birth to 16 years], when scientifically and ethically appropriate.
In a demonstration of ongoing commitment to combatting antimicrobial resistance (AMR), BARDA will support CARB-X for up to 10 additional years for investment in early-stage antibacterial research and development. This new award dedicates an initial $20 million to support the transition of the portfolio, and subsequent option periods for a potential ceiling of up to $300 million. With continued focus on supporting candidate programs to counter the threat of AMR now and in the future, the CARB-X program will provide non-dilutive funding and a full suite of research and development support to product developers worldwide.
Visualize engineering a targeted therapeutic that can overcome drug-resistant infections. BARDA is working with Locus Biosciences to combat antibiotic-resistant E. coli with bacteriophages, harnessing natural predators of bacteria to treat urinary tract infections (UTIs). An estimated 150 million UTIs occur each year worldwide – the majority of which occur in women – highlighting the severity of this issue to women’s health. Explore how BARDA’s investment in Locus’s bacteriophage therapeutic will simultaneously advance this innovative treatment for drug-resistant infections while establishing clinical development strategies for phage-based therapeutics.