6 November 2017 - - Cambridge, Massachusetts-based immune and infectious disease therapeutics developer Vedanta Biosciences, an affiliate of PureTech Health (LSE: PRTC), has been awarded a research grant of up to USD5.4 m from CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator), a global public-private partnership focused on funding the development of promising new antibacterial products and rapid diagnostics, the company said.
The funding will be used to support clinical testing of Vedanta Biosciences' lead oral product candidate, VE303, a novel human-microbiome drug candidate to address Clostridium difficile (C. difficile) and potentially other bacterial infections.
VE303 is a rationally-defined live bacterial consortia administered via an oral capsule and is expected to be tested in a human clinical trial this quarter.
Also in connection with the VE303 program, Vedanta has achieved a key development milestone in the human microbiome field, completing what is believed to be the first-ever CGMP-compliant (Current Good Manufacturing Practices, required by the US Food and Drug Administration) manufacturing of a rationally-defined live bacterial consortia in powder form.
The company has continued to expand its internal, state-of-the-art CGMP-compliant manufacturing capability with the addition of a second manufacturing site, dedicated to production, packaging, and labelling of live bacterial consortia drug product capsules.
Coupled with existing CGMP-compliant drug substance production capabilities in Cambridge, MA, the addition fully integrates Vedanta's manufacturing capabilities, a distinct competitive advantage in the microbiome field.
Vedanta Biosciences' end-to-end platform for development of live bacterial consortia-based medicines based on the human microbiome leverages a vast clinical dataset from interventional studies.
CARB-X is a public-private partnership devoted to antibacterial preclinical R and D. Funded by BARDA and Wellcome Trust, with in-kind support from NIAID, it will spend USD 455m from 2016-2021 to support innovative products moving towards human clinical trials. The partnership focuses on high priority drug-resistant bacteria, especially Gram-negatives.
Vedanta Biosciences is developing a novel class of therapies for immune and infectious diseases based on rationally designed consortia of bacteria derived from the human microbiome.