CARB-X Funds BB100 to Treat Hyper-Virulent Multi-Drug-Resistant E. coli Infections
New alternative-to-antibiotic treatment in development to fight infections associated with E. coli superbug.
CARB-X, a global partnership led by Boston University, is awarding BB100 LLC, a subsidiary of Bravos Biosciences of Schenectady, New York, USA, up to $3.0 million in non-dilutive funding with the possibility of $6.2 million more if certain project milestones are met, to develop a novel monoclonal antibody to prevent or treat serious life-threatening infections caused by a particularly virulent strain of Gram-negative multi-drug-resistant Escherichia coli (E. coli) called ST131-025b, which is often associated with complicated urinary tract, bloodstream, and prostate infections.
“CARB-X continues to increase the number of innovative R&D approaches we support to combat drug-resistant bacteria,” said Kevin Outterson, executive director of CARB-X and professor of law at Boston University. “Patients urgently need new life-saving products and the BB100 approach represents a potential alternative to antibiotics to treat serious infections.”
“We are very excited and appreciative of the CARB-X award.” says Christopher Rubino, PharmD, president of Bravos. “CARB-X support greatly enhances our ability to advance BB100, which holds the promise to be both life-saving and decrease our societal reliance on antibiotics prone to resistance.”
CARB-X funding will support Investigational New Drug (IND) enabling studies, drug manufacturing and the conduct of a Phase 1 clinical study. While still in preclinical development, if approved by regulatory authorities for use in patients, BB100 has the potential to transform the treatment of E. coli infections as it side-steps antibiotic resistance mechanisms.
E. coli bacteria are a frequent cause of cholecystitis, cholangitis, bacteremia, urinary tract and intra-abdominal infections, traveler’s diarrhea, pneumonia and neonatal meningitis. E. coli can be difficult to treat because of emerging antibiotic resistance. Multi-drug resistant E. coli is the world’s most prevalent superbug and is associated with significant morbidity and mortality. Hospitalized patients whose care requires devices like urinary catheters or intravenous catheters are particularly vulnerable.
Driving innovation to address the growing global superbug crisis
According to the World Health Organization, an estimated 700,000 people die each year worldwide from bacterial infections. In the United States alone, an estimated 23,000 people die each year from drug-resistant bacterial infections. In Europe, the number of deaths yearly is estimated at 33,000.
The CARB-X portfolio, the world’s largest antibacterial development portfolio with 30 projects in five countries, is expected to grow significantly this year. Since its inception in 2016, CARB-X has announced awards exceeding $130.5 million, with the potential of additional funds if project milestones are met, to accelerate the development of antibacterial products. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and graduate from CARB-X and others fail for a variety of reasons. In total since it was established, CARB-X has announced awards for 45 projects.
Partnership driving antibacterial innovation
CARB-X is investing more than $500 million in antibacterial R&D between 2016 and 2021. The goal is to support projects through the early phases of development through Phase 1, so that they will attract additional private or public support for further clinical development and approval for use in patients. CARB-X funding is restricted to projects that target drug-resistant bacteria highlighted on the Centers for Disease Control and Prevention (CDC)’s 2013 Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO in 2017—with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.
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 (UK GAMRIF), the Bill & Melinda Gates Foundation, and 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 headquartered at the Boston University School of Law.
Part of CARB-X’s award for BB100 will come from funds provided by the UK Government’s Global AMR Innovation Fund (GAMRIF). GAMRIF is an Official Development Assistance (ODA) fund which allocates support for projects that promote the welfare and economic development of low- and middle-income countries (LMICs). The BB100 project qualifies for the GAMRIF program because the antibody acts against E. Coli ST131-025b, which is responsible for many antimicrobial infections across the globe each year with isolates having been identified in LMICs across Asia, South America and Africa.
This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and awards from Wellcome Trust, the German Federal Ministry of Education and Research, and the Global AMR Innovation Fund (GAMRIF) funded by the UK Government Department of Health and Social Care (DHSC), as administrated by CARB-X. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, other funders, or CARB-X.