BioVersys’ new medicine would be used as a stand-alone to treat uncomplicated skin and skin structure infections (SSSI) or in combination with antibiotics for more severe infections
(BOSTON) – CARB-X is awarding BioVersys AG, headquartered in Basel, Switzerland, up to US $3.94 million in non-dilutive funding, with the possibility of up to $4.98 million more if certain project milestones are met, to develop new drugs designed to disarm Staphylococcus aureus bacteria of virulence factors that can cause serious skin infections and can spread to muscles, lungs and other body parts. The molecules are in development as a stand-alone therapy and for use in combination with existing antibiotics.
“Drug-resistant bacteria represent one of the greatest threats to public health globally. New approaches, like the BioVersys’ project, are urgently needed to help save lives and to curb the spread of drug-resistant bacteria,” said Kevin Outterson, Executive Director of CARB-X, which is based at the Boston University School of Law. “This project is in early stages of development but if successful and approved for use in patients, it would represent tremendous progress in the fight against drug resistance, by offering an alternative therapy to traditional antibiotics and also restoring the effectiveness of existing antibiotics.”
Dr. Marc Gitzinger, CEO and co-founder of BioVersys: “We are delighted that CARB-X recognizes the immense potential of BioVersys’ anti-virulence program (BV200) through this funding award. The diversity in the challenge of antimicrobial resistance (AMR) diseases, requires us to broaden our approach beyond classical antibiotics, and further R&D investment in novel paradigm shifting approaches such as anti-virulence is vitally important. BioVersys is committed to continue its development of novel targeted antimicrobials and deliver new treatment options to AMR patients worldwide.”
The BV200 series of molecules has been developed using the company’s TRIC technology (Transcriptional Regulator Inhibitory Compounds). These are not direct acting antibiotics, but rather a new class of molecules, capable of disarming bacteria of their harmful virulence factors. Molecules of the BV200 class inhibit the transcriptional regulator AgrA which controls the production of harmful virulence factors including -toxin, phenol-soluble-modulin (PSM) and Panton-Valentine leucocidin (PVL) toxins that are directly linked to the severity of S. aureus-mediated skin and skin structure infections( SSSIs) and pneumonia. By preventing the expression of toxins, the molecules have the potential to reduce tissue damage, disease progression and, consequently, reduce infection severity and mortality rates in patients. The BV200 series will initially be developed for skin and skin structure infections (SSSI) and pneumonia caused by S. aureus, including Methicillin-resistant S. aureus (MRSA).
MRSA is identified by the World Health Organization (WHO) as Priority drug-resistant bacteria, and as a Serious Threat to public health by the Centers for Disease Control and Prevention (CDC).
Supporting antibacterial innovation
According to the WHO, an estimated 700,000 people die each year worldwide from bacterial infections. In the US, according to the CDC, 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.
CARB-X is investing up to $500 million in antibacterial R&D between 2016-2021, exclusively targeting drug-resistant bacteria identified by the WHO and CDC as posing the greatest health threats. The goal is to support projects through the early phases of development, through Phase 1 for therapeutics, so that they will attract additional private or public support for further clinical development and approval for use in patients. The CARB-X portfolio, the world’s largest antibacterial development portfolio with 30 projects in five countries. Since its inception in 2016, CARB-X has announced 49 awards exceeding $150 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 others fail for a variety of reasons.
CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), the Wellcome Trust, 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).
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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). A non-profit partnership, CARB-X is investing up to $500 million from 2016-2021 to support the development of 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. https://carb-x.org/. Follow us on Twitter @CARB_X.
BioVersys AG is a privately owned Swiss pharmaceutical company focusing on research and development of small molecules acting on novel bacterial targets with applications in Anti-Microbial Resistance (AMR) and targeted microbiome modulation. With the company’s award-winning TRIC technology we can overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria, towards the identification of new treatment options in the antimicrobial and microbiome fields. By this means BioVersys addresses the high unmet medical need for new treatments against life threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. Our most advanced R&D programs are in preclinical development for nosocomial infections (hospital infections), and Tuberculosis in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille. In 2020 BioVersys plans to launch its first Phase I clinical trials. BioVersys is located in the Technologiepark in the thriving biotech hub of Basel, please visit www.bioversys.com.
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