Vedanta Biosciences, a clinical-stage company developing a potential new category of oral therapies based on defined bacterial consortia, has raised $106.5 million.
The funds will support pivotal-stage development of the U.S. company’s lead candidate, VE303, for the prevention of recurrent Clostridioides difficile infection (CDI), and a phase 2 study of VE202 for ulcerative colitis, among other development activities.
The VE303 study would be the first pivotal phase 3 study of a therapeutic candidate based on a defined bacterial consortium, which Vedanta Biosciences is pioneering as a next-generation approach to microbiome therapy. Defined bacterial consortia are products of standardized composition manufactured from cell banks, bypassing the need to rely on donor fecal material of inconsistent composition.
The investor syndicate was co-led by new investors AXA IM Alts and The AMR Action Fund, along with existing investors 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 existing investors including co-founder PureTech Health, Revelation Partners, QUAD Investment Management, Seventure Partners, Hambro Perks, and Pfizer Inc. also participated.
Bernat Olle, co-founder and chief executive officer of Vedanta Biosciences, said: “Our phase 2 clinical data and this new funding enable us to continue advancing the microbiome field beyond products made from fecal donations, and towards pharmaceutical-grade, defined medicines.”
The primary use of proceeds will be to advance a pivotal phase 3 study of VE303 in recurrent CDI and a proof-of-concept phase 2 study of VE202 in ulcerative colitis. Vedanta Biosciences’ positive phase 2 data for VE303 in recurrent CDI were recently published in the Journal of the American Medical Association (JAMA).
C. difficile causes approximately half a million infections each year in the U.S., including up to 165,000 recurring infections, and has been associated with up to 45,000 deaths annually. The positive results of the phase 2 study, first reported 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.
About Vedanta Biosciences
Vedanta Biosciences is leading the development of a potential new category of oral therapies based on defined consortia of 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 the prevention of recurrent C. difficile infection, inflammatory bowel diseases, food allergy, and liver disease.
Vedanta Biosciences controls a foundational portfolio of more than 70 patents. This platform includes one of the largest libraries of bacteria derived from the human microbiome, datasets from human interventional studies, proprietary capabilities in consortium design, and end-to-end capabilities for CGMP-compliant manufacturing of oral drug candidates spanning cell banking, fermentation, lyophilization, and fill finish.