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CARB-X funds Idorsia to accelerate the early development of a new class of antibiotic to treat deadly drug-resistant bacterial infections

CARB-X funds Idorsia to accelerate the early development of a new class of antibiotic to treat deadly drug-resistant bacterial infections

(BOSTON, MA) – April 20, 2018 – CARB-X announced today a funding agreement with Idorsia (SIX: IDIA.S) of Allschwil, Switzerland, to support the development of a new class of antibiotic, a novel dual-acting topoisomerase inhibitor, to treat patients with infections caused by drug-resistant bacteria. Idorsia will receive an initial award of up to $1.8M from CARB-X, with the possibility of $7.2M more, based on the achievement of certain project milestones. The CARB-X award will support Idorsia’s TopESKAPE program, currently in the lead optimization phase of development.

“With drug-resistance on the rise, it’s vital we speed the development of new classes of antibiotics. The addition of Idorsia’s exciting project to the CARB-X portfolio is another important step in achieving this,” said Kevin Outterson, Executive Director of CARB-X. “The projects in the Powered by CARB-X portfolio are in the early stages of research but, if successful, these projects hold great potential in the treatment of deadly infections and in the fight against drug-resistant bacteria. In addition to the scientific merit of this project, CARB-X was also impressed by the strong record of successful drug development with Idorsia’s management team.”

Idorsia has discovered several new classes of novel bacterial topoisomerase inhibitors (NBTI) with the aim of developing compounds that inhibit two essential bacterial enzymes, DNA gyrase and topo IV, at the same time. The research has shown in vivo efficacy in mouse infection models against Enterobacteriaceae, Pseudomonas and Staphylococci, difficult-to-treat pathogens that cause infections in hospital and health-care settings.

New classes of antibiotics urgently needed
The world urgently needs new antibiotics to treat drug-resistant bacteria. No new classes of approved antibiotics have been discovered since 1962 for the most dangerous types of drug-resistant Gram-negative superbugs. According to the World Health Organization (WHO), an estimated 700,000 people die each year around the world from bacterial infections – and that number is on the rise. According to the CDC, in the United States alone, an estimated 23,000 people die each year from drug-resistant bacterial infections.

The CARB-X portfolio is the world’s largest and most scientifically diverse portfolio of early development antibacterial projects with 30 projects including novel antibiotics and other therapeutics, vaccines and diagnostics to respond to the threat of drug-resistant bacteria. CARB-X, which stands for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, funds projects in 7 countries and is working to expand its pipeline with the best science from around the world.

Since it was established in 2016, CARB-X has announced awards totaling $77.4 million, plus an additional $97.9 million if project milestones are met, to accelerate the development of novel antibiotics and other products. These funds are in addition to investments made by the companies themselves.

Partnership to drive antibacterial innovation
CARB-X is a partnership between the UK charity Wellcome Trust, the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR), and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

CARB-X funding is part of a commitment of up to $455m by the US government and Wellcome Trust from 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 ‘Antibiotic Resistant Threats in the United States’ report published by the Centers for Disease Control and Prevention (CDC) in 2013 or the Priority Bacterial Pathogens list published by the World Health Organization (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.

Responsible use of existing antibiotics and equitable access, particularly in low-income countries where need is greatest, is also vital to addressing the global health problem. Both are a condition of CARB-X funding.

This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust, as administrated by CARB-X. 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, the National Institutes of Health or Wellcome Trust.

Contacts:

CARB-X:
Jennifer Robinson
carbxpr@bu.edu
+1-514-914-8974

Idorsia:
Media.relations@idorsia.com
+41 58 844 10 10

About CARB-X
CARB-X is the world’s largest public-private partnership devoted solely to accelerating early development antibacterial R&D. Funded by ASPR/BARDA and Wellcome Trust, with in-kind support from NIAID, CARB-X is investing up to $455 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, rapid diagnostics and devices to treat drug-resistant bacterial infections. CARB-X focuses on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X operates through Boston University. Other partners include RTI International, the Broad Institute of Harvard and MIT, MassBio, and the California Life Sciences Institute (CLSI). http://www.carb-x.org/.
About Idorsia
Idorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we intend to develop Idorsia into Europe’s leading biopharmaceutical company, with a strong scientific core.
Headquartered in Switzerland – a European biotech hub – Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success. Learn more at www.idorsia.com
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)
About HHS, ASPR and NIH
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the federal public health and medical preparedness and response to disasters and other emergencies, on behalf of the Secretary of HHS. Within ASPR, BARDA provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threat agents, pandemic influenza, and emerging infectious diseases.
NIAID is one of the 27 Centers and Institutes of the National Institutes of Health (NIH) a component of the U.S. Department of Health and Human Services. NIH is the nation’s medical research agency, and is the primary 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. For more information about NIH and its programs, visit www.nih.gov. News releases, fact sheets and other NIAID-related materials are available on the NIAID website: https://www.niaid.nih.gov.
About Boston University
A leading research university with over 33,000 undergraduate and graduate students from more than 130 countries, nearly 10,000 faculty and staff, 17 schools and colleges, and 250 fields of study. Boston University is consistently ranked among the world’s best research universities and is a member of the American Association of Universities. For further information, see www.bu.edu
About the Broad Institute of MIT and Harvard
Broad Institute of MIT and Harvard was launched in 2004 to empower this generation of creative scientists to transform medicine. The Broad Institute seeks to describe all the molecular components of life and their connections; discover the molecular basis of major human diseases; develop effective new approaches to diagnostics and therapeutics; and disseminate discoveries, tools, methods, and data openly to the entire scientific community. Founded by MIT, Harvard, Harvard-affiliated hospitals, and the visionary Los Angeles philanthropists Eli and Edythe L. Broad, the Broad Institute includes faculty, professional staff, and students from throughout the MIT and Harvard biomedical research communities and beyond, with collaborations spanning over a hundred private and public institutions in more than 40 countries worldwide. For further information about the Broad Institute, http://www.broadinstitute.org. In support of CARB-X, the Broad Institute created the Collaborative Hub for Early Antibiotic Discovery (CHEAD), which serves an interdisciplinary center that partners with academic investigators engaged in antibiotic development and/or resistance research to accelerate their early-stage, small molecule therapeutics toward Investigational New Drug (IND) application.
About MassBio
MassBio is a not-for-profit organization founded in 1985 that represents and provides services and support for the world’s leading life sciences supercluster. MassBio is committed to advancing Massachusetts’ leadership in the life sciences to grow the industry, add value to the healthcare system and improve patient lives. Representing 1000+ biotechnology companies, academic institutions, disease foundations and other organizations involved in life sciences and healthcare, MassBio leverages its unparalleled network of innovative companies and industry thought leaders to advance policy and promote education, while providing member programs, events, industry information, and services. Learn more at MassBio
About the California Life Sciences Institute (CLSI)
The mission of the California Life Sciences Institute (CLSI) is to maintain California’s leadership in life sciences innovation through support of entrepreneurship, education and career development. Located in the birthplace of biotechnology, CLSI strives to ensure that the economic and intellectual power of the region’s life sciences industry and its employees remains strong. By maintaining its focus on entrepreneurship, education and career development programs, CLSI supports the foundations of innovation that have made California home to the world’s most prominent life sciences ecosystem. As a non-profit 501(c)(3), CLSI’s objectives are met through collaborations, partnerships, and the generosity of individuals, sponsors and foundations. CLSI is a member of the CARB-X consortium, serving as an accelerator. Learn more at http://califesciencesinstitute.org.
About RTI International
RTI International is an independent, nonprofit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across the social and laboratory sciences, engineering, and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities, and businesses around the world. For more information, visit www.rti.org.