Researchers from the Helmholtz Centre for Infection Research (HZI) and the Lead Discovery Center GmbH (LDC) could receive up to US$8.77 million from CARB-X to develop a new drug to disable S. aureus pathogens thereby preventing lung infections
(BOSTON) – CARB-X is awarding up to US$1.33 million to a German team of researchers to develop a potent first-in-class drug to treat Staphylococcus aureus infections and thereby prevent exacerbation of life-threatening pneumonia. The research team could be eligible for an additional $7.44 million from CARB-X if the project progresses and achieves certain milestones.
The drug is a small-molecule inhibitor of the S. aureus α-hemolysin, a virulence factor responsible for the bacterium’s pathogenicity and ability to cause infection and disease. The drug would disarm the pathogen’s most important toxin that causes damage to lung tissue and immune cells. In doing so, the infection would be halted until the immune system, antibiotic or other therapy eliminates the harmful bacteria.
“Pneumonia caused by S. aureus is a significant health threat around the world, particularly for patients whose immune systems are compromised,” said Erin Duffy, R&D Chief of CARB-X, a non-profit partnership led by Boston University, and dedicated to funding and supporting the development of innovative products targeting antibiotic-resistant bacteria. “The HZI project is an innovative approach that, if successful, has the potential to offer improved treatment of S. aureus infections around the world, particularly in low- and middle-income countries (LMICs), and to save lives.”
The project has a strong intention to make the ultimate product available and suitable for use in both high-income countries and LMIC settings. While much of the work to demonstrate usefulness in LMICs will be done in future stages of the program, there are some basic activities planned in this unit of work that will emphasize utility against S. aureus strains prevalent in LMICs and that will underscore the possibility of dosing regimens (i.e. oral administration) that are particularly important for use in LMICs.
“We urgently need better treatment options for patients with pneumonia caused by S. aureus,” said Mark Brönstrup, head of Chemical Biology at the Helmholtz Centre for Infection Research (HZI), who acknowledged CARB-X’s support as a vital boost for his research. “In the long term, however, we will not achieve this by killing the pathogens with antibiotics alone. Instead, we need preventive or accompanying therapies that prevent damage to the lungs by bacterial toxins.”
Brönstrup’s research is conducted in collaboration with the Lead Discovery Center GmbH (LDC), a spin-off of Max Planck Innovation and the Max Plank Society. Brönstrup also holds a professorship at the German Center for Infection Research (DZIF), based at the Leibniz University Hannover. Researchers will also collaborate with the African Partner Institutions (API) for the clinical development of the α-hemolysin (Hla) inhibitor. CARB-X funding will help researchers progress compounds through preclinical studies and if successful, onto clinical testing in humans.
“We are very pleased about the funding of CARB-X and the international recognition of our drug research at the HZI,” says Dirk Heinz, Scientific Director of the HZI.
“We look forward to the next phase in our close cooperation with the HZI, in which we will be advancing the α-haemolysin inhibitor project as rapidly as possible with the goal of developing a new drug for the treatment of patients with resistant S. aureus infection,” said Dr. Bert Klebl, CEO & CSO of LDC.
CARB-X funding for the HZI project comes from the US Biomedical Advanced Research and Development Authority (BARDA), Wellcome Trust, Germany’s Federal Ministry of Education and Research (BMBF), and the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF).
Supporting global antibacterial innovation to address drug resistance
In a separate announcement today, CARB-X has awarded up to $6.31 million to another team of HZI researchers. The award went to the Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) in Saarbrücken, Germany, to develop an innovative treatment for Pseudomonas aeruginosa infections in cystic fibrosis patients.
The World Health Organization (WHO) estimates that 700,000 people die each year from drug-resistant infections, including 35,000 in the US and 33,000 in Europe. CARB-X funds only projects that target drug-resistant bacteria highlighted on the Priority Bacterial Pathogens list published by the WHO, or on the US Centers for Disease Control and Prevention CDC’s Antibiotic Resistant Threats list, with a priority on those pathogens like S. aureus deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.
The CARB-X portfolio is the world’s largest and most diverse antibacterial R&D portfolio with 49 active projects focused exclusively on drug-resistant bacteria. CARB-X is investing up to $480 million in non-dilutive funding between 2016-2022 to support the early development of new antibiotics, vaccines, rapid diagnostics and other life-saving products. 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 regulatory approval for use in patients.
Since its launch in 2016, CARB-X has announced 75 awards worth more than $260 million, with the potential of additional funds if project milestones are met. These funds are in addition to investments made by the companies themselves. 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 the Wellcome Trust, Germany’s Federal Ministry of Education and Research (BMBF), and the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF). 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.
Helmholtz Centre for Infection Research
Press and Communications
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, 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 investing up to $480 million from 2016-2022 to support innovative antibiotics and other therapeutics, vaccines, 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.
Helmholtz Centre for Infection Research
Scientists at the Helmholtz Centre for Infection Research (HZI) in Braunschweig and its other sites in Germany are engaged in the study of bacterial and viral infections and the body’s defence mechanisms. They have a profound expertise in natural compound research and its exploitation as a valuable source for novel anti-infectives. As member of the Helmholtz Association and the German Center for Infection Research (DZIF) the HZI performs translational research laying the ground for the development of new treatments and vaccines against infectious diseases. www.helmholtz-hzi.de/en
Lead Discovery Center GmbH was established in 2008 by the technology transfer organization Max Planck Innovation of the German Max Planck Gesellschaft e.V., as a novel approach to capitalize on the potential of excellent basic research for the discovery of new therapies for diseases with high medical need. The Lead Discovery Center takes on promising early-stage projects from academia and transforms them into innovative pharmaceutical leads and antibodies that reach initial proof-of-concept in animals as well as candidate nomination. In close collaboration with high-profile partners from research and industry, the Lead Discovery Center is building a strong and growing portfolio of lead and candidate compounds with exceptional medical and commercial potential. The Lead Discovery Center sustains a long-term partnership with the Max Planck Society, KHAN-I GmbH & Co.KG and has formed alliances with Apeiron, AstraZeneca, Bayer, Boehringer Ingelheim, Merck KGaA, Daiichi Sankyo and Qurient, e.g.In addition, LDC also works with leading translational drug discovery centers and with various investors to provide its assets for company creation financed by venture capital firms, like Arix Bioscience and Medicxi, e.g.: www.lead-discovery.de
About BARDA and NIAID
The US Department of Health and Human Services works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. Within HHS, ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. BARDA provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases. NIH is the primary US federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.
About Wellcome Trust
Wellcome exists to improve health for everyone by helping great ideas to thrive. We’re a global charitable foundation, both politically and financially independent. We support scientists and researchers, take on big problems, fuel imaginations and spark debate. The Wellcome Trust is a charity registered in England and Wales, no. 210183. Its sole trustee is The Wellcome Trust Limited, a company registered in England and Wales, no. 2711000 (whose registered office is at 215 Euston Road, London NW1 2BE, UK).
Education and research are the foundations for our future. The promotion of education, science and research by the German Federal Ministry of Education and Research (BMBF) represents an important contribution to securing Germany’s prosperity. Education and research are a Federal Government policy priority, which is reflected in the development of the funding it is making available to these fields.
About the Global AMR Innovation Fund (GAMRIF)
The Department for Health and Social Care (DHSC) is the UK Government department which is responsible for helping people to live more independent, healthier lives for longer.
This research is co-funded by DHSC’s Global AMR Innovation Fund (GAMRIF). GAMRIF was established to provide seed funding for innovative research and development, specifically in neglected and underinvested areas, in the field of antimicrobial resistance (AMR). GAMRIF is a c.£50m UK aid investment, which means all projects funded must support research primarily and directly for the benefit of people in low- and middle-income countries (LMICs). The Fund takes a ‘One Health’ approach, seeking to invest in potential solutions to reduce the threat of AMR in humans, animals, fish and the environment. The Fund seeks to leverage additional global funding through interaction with international government bodies, public-private partnerships, product development partnerships, global funding mechanisms and global fora.
About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With more than 33,000 students, it is the fourth-largest independent university in the United States. BU consists of 17 schools and colleges, along with a number of multi-disciplinary centers and institutes integral to the University’s research and teaching mission. In 2012, BU joined the Association of American Universities (AAU), a consortium of 62 leading research universities in the United States and Canada. For further information, please contact Jeremy Thompson at firstname.lastname@example.org. www.bu.edu.