The round, led by newcomer investors AXA IM Alts and The AMR Action Fund, will let Vedanta begin the phase 3 trial of VE303 by the third quarter of 2023. Among other development activities, Vedanta also plans to use the cash to launch a phase 2 trial of another microbiome therapeutic candidate, VE202, for the treatment of ulcerative colitis in early 2023.
Harnessing the microbiome
Many diseases are linked to disruptions in the gut microbiome, including CDI and ulcerative colitis. Microbiome therapeutics generally consist of giving patients consortia of bacteria derived from the gut microbiome of healthy donors. They are designed to restore the gut microbiome to a healthy state, tackling the cause of the disease. Unlike fecal microbiota transplants, microbiome therapeutics are usually industrially processed and enriched to standardize their quality.
The first microbiome therapeutic was approved by the U.S. Food and Drug Administration (FDA) in late 2022: Ferring Pharmaceuticals’ Rebyota for the prevention of recurrent CDI. Another microbiome therapeutic, Vowst, developed by Seres Therapeutics and Nestlé Health Science, recently became the first FDA-approved orally delivered microbiome therapeutic for preventing recurrent CDI.
In contrast to Rebyota and Vowst, which are derived from stool samples from healthy donors, Vedanta’s candidate VE303 is made up of 8 strains of gut microbiota that are derived from cell banks and selected for their effectiveness against recurrent CDI. VE303 met its primary efficacy endpoint in a phase 2 trial in recurrent CDI in 2021.
“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,” said Bernat Olle, co-founder and CEO of Vedanta Biosciences.
According to Vedanta, the upcoming phase 3 study would be the first to be based on a defined bacterial consortium, and is in part supported by $23.8m from the U.S. Biomedical Advanced Research and Development Authority (BARDA).
New manufacturing facility
Vedanta’s recent financing follows a Series D round worth $68m in 2021. In mid 2022, Vedanta also opened a new manufacturing facility devoted to the production of oral microbiome therapies. The facility was planned to supply its lead candidate for the upcoming phase 3 trial and subsequent commercial launch.
Amongst the large funding rounds and historic product approvals, some players in the microbiome field have faced challenges. Earlier this week, MaaT Pharma emerged from an 18-month clinical hold by the FDA on its pooled microbiome therapeutic technology. And in January 2023, Finch Therapeutics abandoned a phase 3 trial of its microbiome therapeutic candidate for the prevention of recurrent CDI, partly as a result of difficulty in financing the program.