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CARB-X Announces an Award of up to $5.4M to Vedanta Biosciences

CARB-X portfolio now has 23 early development projects with multiple innovative approaches to tackle the most difficult resistant infections.

Powered by CARB-X

CARB-X announced today that it has awarded Vedanta Biosciences of Cambridge, MA (an affiliate of PureTech Health, LSE: PRTC) up to $5.4 million to support the development of a novel, human microbiome-derived treatment for the prevention of bacterial infections caused by C. difficile. Antibiotic use can disrupt the gut microbiota and render patients vulnerable to infection with C. difficile. Vedanta’s oral product candidate, VE303, is a rationally defined live bacterial consortia designed to safely reconstitute a healthy gut microbiota and protect against C. difficile infection. Although C. difficile infections are not yet significantly resistant to the drugs used to treat them, most are directly related to antibiotic use.

“The Vedanta VE303 microbiome-based anti-infective project is an exciting addition to the CARB-X pipeline. It is CARB-X’s first award announced for a microbiome project and also the first for a project targeting C. difficile, bringing a novel approach that could potentially protect patients from bacterial infections and save lives,” said Kevin Outterson, BU Law professor and executive director of CARB-X, the world’s leading non-profit partnership dedicated to accelerating the development of antibiotics, diagnostics and other products to treat deadly infections. “The projects in the Powered by CARB-X portfolio are in the early stages of research, and there is always a high risk of failure. But if successful, these projects hold exciting potential in the fight against the deadliest bacteria.”

“Microbiome-based therapies are a much-needed alternative to antibiotics,” said Bernat Olle, PhD, Vedanta Biosciences CEO. “It is urgent to look for new ways to treat infection that are less prone to eliciting resistance and that do not damage the microbiota and thus render the host vulnerable to re-infection. VE303 has the potential of addressing both of these issues at once.”

The Centers for Disease Control and Prevention (CDC) considers Clostridium difficile (C. difficile) infections one of the most urgent bacterial threats. C. difficile infections account for 15,000 deaths each year in the US alone, and many more die from conditions complicated by C. difficile infections. Global estimates are not available. Current treatments for C. difficile infections include antibiotics, which can further damage the gut microbiome—the community of good bacteria that live in the body – and leave patients vulnerable to serious re-infection. The Vedanta VE303 project aims to rebuild the damaged gut microbiome, and protect against C. difficile.

Vedanta plans to initiate Phase 1 clinical trials with its lead product candidate VE303 in 2017, supported by funding from CARB-X.

The CARB-X portfolio is the world’s largest and most scientifically diverse portfolio of early development projects to treat serious drug-resistant bacterial infections and other difficult-to-treat infections. CARB-X, which stands for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, currently funds projects in six countries and is working to expand its pipeline with the best science from around the world.

CARB-X is a partnership between the 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 (NIH). CARB-X is actively seeking global support from other governments, industry and civil society to expand its ability to fund the best science around the world to get the new life-saving treatments so urgently needed.

BARDA’s Director Rick Bright, PhD, said: “The support announced today aims to speed development of a potential new antibacterial product to treat patients with life-threatening infections and enhance national security and global health preparedness. At BARDA, 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.”

Tim Jinks, head of Drug-Resistant Infections at Wellcome Trust, said:“Wellcome is committed to addressing this urgent global health threat. With drug-resistant infections spreading rapidly it’s vital we speed discovery of new and innovative treatments. The addition of this exciting project to the CARB-X portfolio is another important step in achieving this. Drug discovery must also go hand-in-hand with concerted action to ensure responsible use of antibiotics and availability of existing and new treatments for patients in all countries.”

CARB-X funding is part of an overall commitment of up to US$455 million by the US government and Wellcome Trust over a five-year period from 2016 to 2021. So far this year, including the Vedanta award, CARB-X has announced $57.5 million to help fund 23 projects plus an additional $72.15 million if project milestones are met. These funds are in addition to investments by the companies. 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.

CARB-X’s role is to identify and fund promising early research in antibiotics, vaccines and rapid diagnostics to treat the most serious bacterial infections. The goal is to support projects through the early phases so that they will attract additional private or public support for clinical development.

CARB-X expects to make further funding announcements later this year.

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