Vedanta Biosciences, a clinical-stage company developing a potential new category of oral therapies based on defined bacterial consortia, announced today that it has raised $106.5 million in funding to support pivotal-stage development of its lead candidate, VE303, for the prevention of recurrent Clostridioides difficile infection CDI, as well as a Phase 2 study of VE202 for ulcerative colitis, among other development activities.
The VE303 study would be the first pivotal Phase 3 research of a treatment candidate based on a specified bacterial consortia, a next-generation approach to microbiome medicine pioneered by Vedanta. Defined bacterial consortia are uniform composition products created from cell banks, eliminating the need to rely on donor fecal material of variable composition.
New investors AXA IM Alts and The AMR Action Fund co-led the investor syndicate, which included current investors Bill & Melinda Gates Foundation, Skyviews Life Science, Reimagined Ventures, Fiscus Ventures, PEAK6, and Atlantic Neptune.
New investors included K2 HealthVentures, Korea Investment Partners, Korea Investment & Securities Asia Ltd., and Korea Investment & Securities US, Inc., as well as existing investors such as PureTech Health’s co-founder, Revelation Partners, QUAD Investment Management, Seventure Partners, Hambro Perks, and Pfizer Inc.Proceeds will be used primarily to fund a key Phase 3 investigation of VE303 in recurrent CDI and a proof-of-concept Phase 2 study of VE202 in ulcerative colitis.
The Journal of the American Medical Association (JAMA) recently released promising Phase 2 data for Vedanta’s VE303 in recurrent CDI. C. difficile causes around 500,000 infections in the United States each year, including up to 165,000 recurring infections, and has been linked to up to 45,000 deaths.
The favorable Phase 2 trial results, which were announced in October 2021, triggered a $23.8 million contract option from the Biomedical Advanced Research and Development Authority (BARDA) to support a Phase 3 clinical study of VE303.
This project was partially financed by the Department of Health and Human Services’ Administration for Strategic Preparedness and Response; BARDA, under contract number 75A5012C00177, with a contract value of up to $81.9 million.
Curt LaBelle, M.D., Martin Heidecker, Ph.D., and Neil Tiwari will join Vedanta’s Board of Directors as part of their investment.
Dr. LaBelle has over twenty years of experience investing in and working with healthcare firms and is the Managing Partner of Global Healthcare Strategies at AXA IM Alts. Dr. Heidecker is the Chief Investment Officer of The AMR Action Fund and has over twenty years of international experience in venture capital, medical development, and pharmaceutical marketing.
Vedanta Biosciences is driving the development of a potentially new class of oral medicines that are based on specific consortia of bacteria identified from the human microbiome and cultured from pure clonal cell banks.
Product candidates in the company’s clinical-stage pipeline are being studied for the prevention of recurrent C. difficile infection, inflammatory bowel disease, food allergy, and liver disease.
These experimental therapies are based on our team’s groundbreaking research, which has been published in prestigious journals such as Science, Nature, Cell, and JAMA, to identify beneficial bacteria that live symbiotically within the healthy human gut, fight pathogens, and induce a variety of potent immune responses.
