Funding and study to support treatment to stop recurrent infection and ulcerative colitis

By Liza Laws

- Last updated on GMT

© Getty Images
© Getty Images

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A company developing a potential new category of oral therapies based on defined bacterial consortia has made two big announcements this week (April 25).

Vedanta Biosciences, a clinical-stage company, has raised $106.5million to support its lead candidate VE303 that aims to stop recurrent Clostridioides difficile​ infection (CDI). The company has also announced a phase 2 study of VE202 for ulcerative colitis. It says these are among other development activities.

The VE303 study would be the first phase 3 study of a therapeutic candidate based on a defined bacterial consortium, which Vedanta is promoting 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 CEO of Vedanta Biosciences, said: “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.

“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 funding will mainly be used to advance the phase 3 study of VE303 and as a proof of concept study of VE202 in ulcerative colitis.

Positive phase 2 data for VE303 in recurrent CDI were recently published in the Journal of the American Medical Association​ (JAMA)​.

The company says that 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.

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