VEDANTA BIOSCIENCES Cambridge, MA
Fighting superbugs by boosting the body’s own microbiome
Vedanta’s VE303 microbiome project is the first rationally-defined bacterial consortium in powder form to advance into clinical trials as a potential treatment of deadly bacterial infections
Vedanta Biosciences is pioneering development of novel therapies for infectious and immune-mediated diseases based on rationally-defined consortia of bacteria derived from the human microbiome. An affiliate of PureTech Health (LSE: PRTC), Vedanta’s co-founders include world-renowned experts in immunology and microbiology.
Vedanta’s lead program, VE303, is a rationally-defined bacterial consortium designed to colonize the gut and safely outcompete Clostridium difficile (C. difficile), while reconstituting gut microbiota previously disrupted by antibiotic treatment. A part of the CARB-X program, Vedanta’s VE303 program received Orphan Drug Designation from the FDA and began a Phase 1 clinical trial in 2017, having dosed a human with what is believed to be the first rationally-defined bacterial consortium in powder form to advance into the clinic in any indication.
“The initiation of this study marks an important milestone for both Vedanta Biosciences and the microbiome field, as we’ve been able to advance a new class of drugs to the clinic,” said Bernat Olle, Ph.D., Chief Executive Officer of Vedanta Biosciences. “First-generation approaches in the microbiome field have relied on uncharacterized fecal material or spore fractions of fecal material, which are inherently inconsistent procedures. Products with a rationally-defined composition are the next logical step in the evolution of the microbiome field. We believe VE303 is the first rationally-defined bacterial consortium in powder form to advance into the clinic in any indication, and we plan to rapidly advance two additional programs into clinical development in 2018.”
The Centers for Disease Control and Prevention (CDC) considers C. difficile 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. Often, C. difficile infections occur in hospitalized or recently hospitalized patients. 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. Vedanta’s VE303 project aims to rebuild the damaged gut microbiome to protect against C. difficile.
Vedanta is a leader in the microbiome field with capabilities and deep expertise to discover, develop and manufacture drugs based on live bacterial consortia. Vedanta maintains an integrated manufacturing operation providing cGMP-compliant manufacturing of rationally-defined bacterial consortia in powder form. Leveraging its proprietary technology platform and the expertise of its scientific co-founders, Vedanta has isolated and maintains what we believe to be the largest collection of human microbiome-associated bacterial strains and has characterized how the immune system recognizes and responds to these microbes. This pioneering work has led to the identification of human commensal bacteria that induce a range of immune responses and characterized the novel molecular mechanisms of microbial-host communication, which have been published in leading peer-reviewed journals. Vedanta has harnessed these insights, its proprietary library of bacterial strains, and data from collaborations, to generate a pipeline of programs addressing infectious diseases, autoimmune diseases, inflammation and immune-oncology indications. Moreover, Vedanta holds broad patents covering pharmaceutical compositions including Clostridium bacterial strains and methods of use for therapeutic products, including consortia of bacterial strains and spore-forming fractions based on beneficial bacteria.
Did you know?
A 2015 CDC study found that C. difficile caused almost half a million infections among patients in the United States in a single year. An estimated 15,000 deaths are directly attributable to C. difficile infections, making it a substantial cause of infectious disease death in the United States. The CDC estimates that up to $3,800,000,000 in medical costs could be saved over 5 years if a cure were found.
Published on January 23, 2018