Debiopharm’s new Debio 1454 is the company’s second project to be awarded CARB-X support
(BOSTON, USA) – CARB-X is awarding Debiopharm International SA of Lausanne, Switzerland, up to $2.1 million in non-dilutive funding with the possibility of $1.6 million more if certain project milestones are met, to advance the development of a new class of antibiotics that inhibit bacterial fatty acid biosynthesis, an essential pathway in many drug-resistant bacterial species. This new class of antibiotics is in development for the treatment of hospital-acquired pneumonia caused by the multidrug-resistant superbug Acinetobacter baumannii.
“The world urgently needs new approaches, new classes of antibiotics and rapid diagnostics to treat infections caused by drug-resistant bacteria. Debiopharm’s Debio 1454 project represents an exciting new class of antibiotics, that if successful and approved for use in patients, could save lives and be a huge step forward in the global fight against drug resistance,” said Kevin Outterson Executive Director of CARB-X and professor of law at Boston University. “We are making solid progress in supporting antibacterial innovation, but we know that much more is needed. It will take increased investment and concerted global leadership to deliver the antibiotics and other life-saving products we need to address the superbug crisis.”
Gregoire Vuagniaux, Director of Translational Science of Debiopharm International SA said: “CARB-X’s grant will help support the development of Debio 1454, a new class of antibiotics targeting A. baumannii, one of the priority 1 critical pathogens identified by the WHO. We are really excited to continue developing innovative antibiotics that not only target specific priority pathogens but also spare the natural microbiome, reducing the potential for dysbiosis and development of resistance.”
FabI is essential for several bacterial species, including multi-drug resistant A. baumannii, a rapidly emerging pathogen that causes infections including pneumonia, meningitis, urinary tract infection, and wound infection. This organism’s ability to survive under a range of environmental conditions and to persist for extended periods of time on exposed surfaces makes it a frequent cause of infectious disease outbreaks in health-care settings. These resilient bacteria present a concern for hospitalized patients with weakened immune systems as they are particularly vulnerable.
FabI inhibitors work by inhibiting an essential fatty acid biosynthesis protein. This disruption prevents the bacteria from manufacturing critical fatty acid cellular components, weakening cell membranes and the cell wall, ultimately leading to bacterial cell death.
According to the World Health Organization, an estimated 700,000 people die each year worldwide from bacterial infections. In the United States, 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.
This represents Debiopharm’s second project to be funded by CARB-X. In 2017, CARB-X announced support for the development of Debio 1453, a novel antibiotic FabI inhibitor targeting the Neisseria gonorrhoeae superbug, the causative bacterium in the spread of sexually transmitted difficult-to-treat gonorrhea.
Partnership driving antibacterial innovation globally
The CARB-X portfolio is the world’s largest antibacterial development portfolio with 29 projects in five countries, and is expected to increase significantly this year. Since its inception in 2016, CARB-X has announced awards for 43 projects in seven countries exceeding $118 million, with the possibility 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. In addition to funding, CARB-X provides business and scientific support for projects through the CARB-X Global Accelerator Network, a network of 10 expert organizations around the world. The CARB-X pipeline will continuously evolve, as projects progress and others fail for a variety of reasons.
CARB-X recently announced four new funding rounds for 2019, each with a specific scope and application period in the coming months. Product developers from around the world are invited to apply for funding and support for non-traditional therapeutics, vaccines and biotherapeutics, diagnostics, and direct-acting small molecule antibiotics.
CARB-X is investing up to $550 million in antibacterial R&D between 2016-2021. 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. The scope of CARB-X funding is restricted to projects that target drug-resistant bacteria highlighted on the Centres 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.
This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust. 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, Wellcome Trust, or other CARB-X funders.
Debiopharm International SA:
Christelle von Büren
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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 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 U.S. 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) within the U.S. Department of Health and Human Services. A non-profit partnership, CARB-X is investing up to $550 million from 2016-2021 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 focuses exclusively on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X is headquartered at Boston University School of Law. https://carb-x.org/. Follow us on Twitter @CARB_X
About Debiopharm International SA
Part of Debiopharm Group™, Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company identifies promising drug candidates from in-licensing partners for early clinical development. The products are then out-licensed for commercialization by pharmaceutical partners to give access to the largest number of patients possible worldwide.
For more information, please visit www.debiopharm.com
We are on Twitter. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews
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 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.
The partnership with CARB-X is part of DHSC’s Global Antimicrobial Resistance 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 AMR. GAMRIF is a £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.