An affiliate of PureTech Health, Vedanta Biosciences, has been awarded a research grant of up to $5.4 million from Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to support clinical testing of its lead oral product candidate, VE303.
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VE303 is a rationally-defined live bacterial consortia that is administered via an oral capsule to treat Clostridium difficile (C. difficile) and potentially other bacterial infections. Human clinical trials of the drug candidate are expected to start this quarter.
“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, 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
“First-generation approaches in the microbiome field for recurrent C. difficile infection (rCDI) have relied on uncharacterised faecal material or spore fractions of faecal material, which are inherently inconsistent procedures,” explained Bernat Olle, PhD, chief executive officer of Vedanta Biosciences. “We believe that VE303 is the first rationally-defined microbiome drug advanced to the clinic to tackle rCDI. VE303 is produced from pure cell banks and it consists of a defined consortia of live bacteria designed to restore colonisation resistance against gut pathogens following recurrence. We are grateful to CARB-X for their support and look forward to working together to advance this novel therapy.”
Additionally, the company has revealed that it has achieved a key development milestone in the human microbiome field, completing a cGMP-compliant manufacture of a rationally-defined live bacterial consortia in powder form.
“Reproducible cGMP-compliant manufacturing of live bacterial consortia drugs can be a complex activity, and we have worked successfully through those technical hurdles,” added Dan Couto, SVP of Operations and Manufacturing for Vedanta Biosciences. “Completion of this technical milestone significantly de-risks the company’s ability to supply timely clinical material for our pipeline of programmes and provides Vedanta a key strategic advantage in the microbiome field.”