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CARB-X funding for global scientists racing to discover new antibiotics to treat superbugs

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Scientists developing promising new antibiotics in India, Ireland, France, Switzerland, the US and UK are to share up to US$17.6m to speed treatments for the world's deadliest superbugs.

A year since launching, the international partnership CARB-X today announces its second round of antibiotic research and development funding — alongside a call for greater global support.

The seven projects supported include:

  • Five potential new class antibiotics for Gram-negative bacteria
  • Potential new treatment for drug-resistant gonorrhea
  • New molecule targeting a superbug causing serious infections in cystic fibrosis patients
  • Phase 1 clinical trial of a new oral broad-spectrum antibiotic

Drug-resistant infections currently cause around 700,000 deaths worldwide annually — if antibiotic resistance continues at its current rate that could rise significantly within a generation.

Kevin Outterson, Executive Director of CARB-X and Professor of Law at Boston University said: "Drug-resistant infections are complex and developing new antibiotics challenging, timely and costly. But restoring the R&D pipeline is vital to address the seriously increasing threat of superbugs which have become resistant to existing drugs. This is a global problem and CARB-X is a critical part of the global solution. We are looking to support the best potential new treatments and diagnostics across the world. We are especially pleased that today's awards mean we are now supporting scientists in six countries. The projects offer exciting potential. But we need greater global support from governments, industry and civil society to get the new treatments the world urgently needs."

CARB-X – which stands for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator — is a partnership between UK charity Wellcome Trust and 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, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

CARB-X was launched in July 2016 to address the gap in antibiotic research and development and innovations to improve diagnosis and treatment of drug-resistant infections. The G20 has called for global antibiotic R&D efforts like CARB-X to refill the pipeline with safe and effective drugs.

Antibiotic discovery is challenging due to the complexity of bacteria which are easily able to genetically modify and become resistant to medicines, but also because of declining investment by larger companies.

The most recently approved new class of antibiotics was discovered in the early 1980s. However, CARB-X funding is focused on the most resistant, Gram-negative, bacteria, and the last new class of antibiotics approved for treatment against these was discovered in 1962.

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

Tim Jinks, Head of Drug-Resistant Infections at Wellcome said: "Antibiotics are fundamental to modern medicine but overuse and inappropriate use have led to dangerous bacteria developing deadly resistance. Wellcome is committed to helping ensure we get the urgently needed new treatments. Drug discovery must also go hand-in-hand with concerted action to ensure antibiotics of last resort are reserved for patients where first-line treatments will not work. And we must ensure these treatments can be made available in all countries for those who need them."

Today's funding announcement is for one company in France, one in India, one in Switzerland, two in the US, one in the UK and one in Ireland.

Many of the CARB-X projects are at an early stage and it will still take some time before it is known whether they can become safe, effective treatments for patients. CARB-X is also supporting a Phase 1 clinical trial of a new oral and intravenous broad-spectrum antibiotic. Ensuring appropriate use of this type of antibiotic is critical – and used appropriately it can save lives.

BARDA's Director Rick Bright, Ph.D., said: "The support announced today will help speed development of new antibacterial products to treat patients with serious, life-threatening infections to enhance domestic health security and global preparedness. We are committed to revitalizing the antibacterial pipeline through a combination of incentives; today's announcement is another example of our commitment to promote and accelerate medical countermeasure innovation through novel public-private partnerships like CARB-X."

"These awards build upon the scientific opportunities created by prior NIAID investments in drug development programs to assist with antibiotic development, and are consistent with our strategies for new approaches to address antibiotic resistance," said NIAID Director Anthony S. Fauci, M.D.

This latest funding is part of an overall commitment of up to US$455m by the US government and Wellcome over a five year period and follows the announcement in March 2017 of the first 11 projects to receive funding — eight in the US and three in the UK.

The projects were selected from among 368 applications from around the world. CARB-X expects to make further funding announcements later this year. Product developers can visit CARB-X.org for additional information on funding opportunities.

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Contacts:

Wellcome Trust: Maggie Stratton +44 (0) 207 611 8609, [email protected]

CARB-X: Jennifer Robinson +1-514-914-8974 [email protected]

Notes to Editors:

  • CARB-X was created in response to the US government's 2015 National Action Plan for Combating Antibiotic Resistant Bacteria (CARB) and the UK government's call in 2016 for a concerted global effort to tackle antibiotic resistance. A non-profit partnership, it is headquartered at Boston University. CARB-X was launched by the US Department of Health and Human Services (HHS)'s Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID/NIH). Initial funders are BARDA and Wellcome Trust. NIAID provides preclinical services support. Other partners include the Broad Institute of MIT and Harvard, the Massachusetts Biotechnology Council (MassBio), the California Life Sciences Institute (CLSI), and RTI International. CARB-X projects are selected through a global competitive process. Applications are vetted by the CARB-X Advisory Board, comprised of leading antibiotic experts. To be considered, projects must target one of the antibiotic resistant bacteria on the Serious or Urgent Threat List prepared by the CDC or on the Priority Pathogens list published by the WHO. BARDA funding is provided to CARB-X under Cooperative Agreement 5 IDSEP160030-02-00.

Further information on funded projects announced July 2017:

Achaogen Inc.: Progressing a new class of antibiotics into Phase 1 trials – LpxC inhibitors to treat Pseudomonas aeruginosa Initial investment of up to $3.2m with potential option payments up to $8.2

Achaogen is developing a new class of antibiotics that inhibit LpxC, an essential enzyme unique to Gram-negative bacteria. Achaogen's lead LpxC inhibitor has the potential to treat infections due to multidrug-resistant Pseudomonas aeruginosa, one of the drug-resistant bacteria on the World Health Organization's top priority list, and positively impact the excess morbidity and mortality in affected patients. Funding under CARB-X will support Achaogen in advancing their lead LpxC inhibitor through initial Phase 1 clinical trials, with the potential to bring a new class of antibiotic with activity focused on Gram-negative infections to patients for the first time in decades. Achaogen (NASDAQ:AKAO) is a South San Francisco-based late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterial treatments for multi-drug-resistant Gram-negative infections. For information: http://www.achaogen.com/. Media contact: Denise Powell at [email protected]

Antabio SAS: Developing a novel virulence-inhibitor that can boost the effect of antibiotics in the treatment of Cystic fibrosis.

Initial investment of up to $2.8m with potential option payments up to $6.1m

Cystic fibrosis (CF) is a genetic condition leading to long-term infections and progressive lung damage. The most frequent infection in adult patients is caused by the bacterium Pseudomonas aeruginosa (PA), which grows as biofilm clusters that are resistant to immune clearance and conventional antibiotics. CARB-X funding will help support Antabio's Pseudomonas Elastase Inhibitors (PEI) project. The PEI project seeks to develop inhibitors of the PA LasB elastase virulence factor, thereby targeting the bacterium's ability to evade the immune system and cause disease, and when given alongside antibiotics, helping to clear PA infections. Antabio is a private biopharmaceutical company developing novel resistance-inhibitors that can be combined with antibiotics to treat drug-resistant infections caused by the most critical Gram-negative pathogens. Antabio is headquartered in Labège, France. For information: http://www.antabio.com. Media contact: [email protected]

Bugworks Research India Pvt Ltd: Developing a new class of antibiotics to inhibit bacterial DNA topoisomerases

Initial investment of up to $2.6m with potential option payments up to $3.6m

In partnership with CARB-X, Bugworks is developing a novel first in class broad-spectrum antibiotic to kill multi-drug resistant Gram-negative bacteria that have been identified by the World Health Organization as critical and high priority infection threats. Our lead compound, a Gyrase-topoisomerase inhibitor, is being developed as an intravenous and oral treatment for multi-drug resistant infections, with a low risk of developing resistance because it inhibits two essential targets in the replication machinery and has been designed to by-pass efflux resistance mechanism of the bacteria. In pre-clinical testing, Bugworks' novel broad-spectrum antibiotics have demonstrated efficacy against deadly Gram-negative superbugs. Bugworks is based in Delaware, US, and operates its R&D facilities in Bangalore, India. For information: http://bugworksresearch.com/ Media contact: Anand AnandKumar at [email protected]

Debiopharm International SA: Developing a new class of antibiotics to treat drug-resistant gonorrhea

Initial investment of up to $2.6m with potential option payments up to $1.4m

Debiopharm International SA, a Swiss-headquartered global biopharmaceutical company, has developed a novel class of antibiotics which inhibit bacterial fatty acid biosynthesis, an essential pathway in major pathogens including Neisseria gonorrhoeae, the causative bacterium in the sexually transmitted disease gonorrhea. N. gonorrhoeae's resistance to antibiotics is a major global medical problem having acquired resistance to practically all classes of antibiotics (CDC). Debiopharm, in collaboration with CARB-X, will utilize their state-of-the-art Fabiotics drug discovery platform to develop novel therapeutics to combat drug-resistant gonorrhea. For information: http://www.debiopharm.com. Media contact: Christelle Tur at [email protected]

EligoChem Ltd.: Antimicrobial peptides have the potential to be potent antibiotics to treat drug-resistant Gram-negative bacteria

Initial investment of up to $1.5m with potential option payments up to $3.3m

ligoChem Limited is progressing a project, powered by CARB-X, to select and develop antimicrobial peptides as Gram-negative antibiotics. The CARB-X funded project focuses on candidate selection from of a series of helical antimicrobial peptides with potent Gram-negative antibiotic action and low frequency of resistance potential. These peptides have significantly reduced toxicity potential compared to other known antimicrobial peptides. EligoChem is based in Discovery Park, Kent, UK, and focused on the design of amphiphilic compounds that possess good absorption and low attrition risks, particularly suited to antibiotic research. For more information: http://www.eligochem.com. Media contact: Andy McElroy at [email protected]

Iterum Therapeutics: Oral and intravenous formulations of sulopenem under investigation in Phase 1 clinical trials for the treatment of serious drug-resistant infections

Investment of up to $1.5m

Sulopenem, which is being supported by CARB-X funding, is an antibiotic under study for the treatment of infections caused by multi-drug resistant bacteria in hospital and community settings. These include the most urgent drug-resistant antimicrobial threats defined by the US Centers for Disease Control. Sulopenem is highly effective against the pathogens most commonly associated with uncomplicated urinary tract infections, complicated urinary tract infections and complicated intra-abdominal infections, including potent in-vitro activity against Enterobacteriaceae mutants of E. coli and K. pneumonia. If approved, sulopenem will be available as a tablet and an intravenous formulation. Future clinical studies will focus on urinary tract and complicated intra-abdominal infections. With careful stewardship from medical professionals and appropriate use by patients, sulopenem could be effective in the treatment of infections in patients in the community and could be useful in the early discharge of patients from hospital. Iterum Therapeutics is headquartered in Dublin, Ireland. For more information: http://www.iterumtx.com. Media contact: Stephen Lederer at [email protected]

VenatoRx Pharmaceuticals: Working to discover a new class of antibiotic that beats resistance caused by beta-lactamase enzymes

Initial investment of up to $3.4m with potential option payments up to $6m

VenatoRx Pharmaceuticals is aiming to develop a new antibiotic class that circumvents the most prevalent form of antibiotic resistance. Since the discovery of penicillin, dozens of drugs, collectively known as beta-lactams, have been introduced that kill bacteria by targeting their cell wall. Unfortunately, bacteria have developed hundreds of beta-lactamase enzymes that prevent these drugs from working. VenatoRx has found a new drug class that kills bacteria by hitting the same cell wall target, but is impervious to beta-lactamase enzymes. VenatoRx is a private pharmaceutical company dedicated to the discovery and development of novel anti-infective agents. It is headquartered in Malvern, PA, USA. For more information: http://www.venatorx.com. Media contact: [email protected]

Boilerplates

About CARB-X

CARB-X is the world's largest public-private partnership devoted to early stage antibacterial R&D. Funded by BARDA and Wellcome Trust, with in-kind support from NIAID, we will spend up to $455 million from 2017-2021 to support innovative products from 'hit-to-lead' stage through to Phase 1 clinical trials. CARB-X focuses on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X is a charitable global public-private partnership led by Boston University. Other partners include the Broad Institute of Harvard and MIT, MassBio, the California Life Sciences Institute and RTI International. For more information, please visit http://www.carb-x.org and follow us on Twitter @CARB_X.

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 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 http://www.bu.edu or contact Ann Comer-Woods [email protected]

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 leads HHS's efforts to prepare the nation to respond to and recover from adverse health effects of emergencies, supporting communities' ability to withstand adversity, strengthening health and response systems, and enhancing national health security. 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.

NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH 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 http://www.nih.gov. News releases, fact sheets and other NIAID-related materials are available on the NIAID website: https://www.niaid.nih.gov.

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, go to 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. For further information about CHEAD, go to https://www.broadinstitute.org/infectious-disease-and-microbiome/carb-x-collaborative-hub-early-antibiotic-discovery.

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.

About the California Life Sciences Institute (CLSI)

The California Life Sciences Institute (CLSI) supports the foundations of innovation that have made California home to the world's most prominent life sciences ecosystem. With a focus on the San Francisco Bay Area, CLSI's mission is to maintain California's leadership in life sciences innovation through support of entrepreneurship, education and career development. CLSI is a member of the CARB-X consortium, serving as an accelerator. CLSI is an affiliate of the California Life Sciences Association (CLSA), which represents California's leading life sciences organization. The California Life Sciences Institute is a non-profit 501(c)(3), and was established in 1990 as the BayBio Institute. 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 http://www.rti.org.

Media Contact

Maggie Stratton
[email protected]
44-020-761-18609
@wellcometrust

http://www.wellcome.ac.uk

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