India Pharma Outlook Team | Friday, 28 April 2023
Vedanta Biosciences, a clinical-stage company developing a potential new class of oral therapies based on defined bacterial consortia, announced a $106.5 million funding round 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 standardised composition products created from cell banks, eliminating the need to rely on donor faecal 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. "We are grateful to have the support of our new and existing investors, who share our vision of pioneering microbiome therapeutics based on defined bacterial consortia to transform the lives of patients with serious diseases," said Bernat Olle, co-founder and CEO of Vedanta Biosciences. "Our phase 2 clinical data and this new funding enable us to continue advancing the microbiome field beyond products made from faecal 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’s 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 United States, 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. This project has been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A5012C00177 for a contract value up to $81.9 million. Curt LaBelle, Martin Heidecker, 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. Tiwari has over fifteen years of healthcare expertise as an operator, investor, and board member in medical devices, pharmaceuticals, biotechnology, and health technology, and is a Magnetar Capital healthcare, life sciences, and technology investor. In addition, two directors will conclude their tenure on Vedanta’s board, including Christopher Viehbacher, recently appointed chief executive officer of Biogen Inc., and Bharatt Chowrira, Ph.D., J.D., the president, chief business, legal and operating officer of PureTech Health. Charles Sherwood III, Associate General Counsel at PureTech, will replace Dr. Chowrira on the Vedanta Board of Directors.
“We extend our warm thanks to Chris and Bharatt for their several years of expert guidance and contributions to advancing our mission, and welcome our new Board members,” said Dr. Olle. FJS Consultants Limited acted as a placement agent for Vedanta’s new investors in Korea. Defined Bacterial Consortia are assemblies of bacteria of standardized composition that act cooperatively to exert a therapeutic effect.
The constituent strains in each consortium are rationally selected from Vedanta’s extensive in-house strain library, and grown from pure, clonal cell banks using scalable fermentation processes. Each capsule contains precisely controlled compositions and doses of the same live bacterial strains and is formulated for stable oral delivery to the lower gastrointestinal tract. We believe that our targeted approach offers consistent composition and quality attributes, may provide more consistent clinical benefit, limits safety risk, and enables greater scalability compared with fecal-derived approaches.
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