Vedanta Biosciences, a clinical stage company developing potential new categories of oral therapy based on select bacteria consortia, has raised $106.5 million.
The funds will support the development of an important stage of the US company’s prime candidate, VE303, for recurrent disease prevention. Clostridioides is difficult infection (CDI), and the VE202 phase 2 study for ulcerative colitis, among other developmental activities.
The VE303 study will be the first important phase 3 study of a therapeutic candidate based on a defined bacterial consortium, pioneered by Vedanta Biosciences as a next-generation approach to microbiome therapy. The defined bacterial consortium is a standard composition product prepared from a cell bank, bypassing the need to rely on donor stool materials with inconsistent composition.
The investor syndicate is co-led by new investors AXA IM Alts and The AMR Action Fund, along with existing investors the Bill & Melinda Gates Foundation, Skyviews Life Science, Reimagined Ventures, Fiscus Ventures, PEAK6, and Atlantic Neptune. New investors K2 HealthVentures, Korea Investment Partners, Korea Investment & Securities Asia Ltd. and Korea Investment & Securities US, Inc., and past investors include co-founders PureTech Health, Revelation Partners, QUAD Investment Management, Seventure Partners, Hambro Perks, and Pfizer Inc. also participate.
Bernat Olle, co-founder and chief executive officer of Vedanta Biosciences, said: “Our phase 2 clinical data and this new funding allow us to continue advancing the microbiome field beyond products made from faecal donation, and towards pharmaceutical-grade defined drugs. ”
The primary use of the results is to advance the important phase 3 study of VE303 in recurrent CDI and the phase 2 proof of concept study of VE202 in ulcerative colitis. Vedanta Biosciences positive phase 2 data for VE303 in recurrent CDI was recently published in the Journal of the American Medical Association (JAMA).
Difficult cause about half a million infections annually in the US, including up to 165,000 recurrent infections, and have been linked to 45,000 deaths annually. Positive results from the phase 2 study, which were first reported in October 2021, triggered a $23.8 million contract option from the Biomedical Advanced Research and Development Authority (BARDA) to support the phase 3 clinical study of VE303.
About Vedanta Biosciences
Vedanta Biosciences is leading the development of a potential new category of oral therapy based on a consortium of specific bacteria isolated from the human microbiome and grown from pure clonal cell banks.
The company’s clinical stage pipeline includes product candidates being evaluated for relapse prevention Difficult infections, inflammatory bowel disease, food allergies, and liver disease.
Vedanta Biosciences controls a basic portfolio of more than 70 patents. The platform includes one of the largest libraries of bacteria derived from the human microbiome, datasets from human intervention studies, proprietary capabilities in consortium design, and end-to-end capabilities for the creation of CGMP-compliant oral drug candidates that include cell banking, fermentation, lyophilization, and final contents.