Vedanta Biosciences has initiated a Phase I clinical study of its live biotherapeutic product (LBP) candidate VE202 for the treatment of inflammatory bowel disease (IBD).

The study is being conducted by Janssen Research & Development and will involve healthy volunteers.

Vedanta is set to receive $12m in milestone payments from Janssen in conjunction with the initiation of this study and as part of an ongoing collaboration.

The partnership contains up to a total of $339m in development and commercialisation milestone payments, exluding royalties.

“VE202 is the first drug candidate based on a rationally-defined bacterial consortium to enter the clinic for an autoimmune disease.”

Vedanta Biosciences co-founder and CEO Bernat Olle said: “There is significant evidence highlighting the role of the microbiome in the pathogenesis of IBD.

“Current treatments effectively block mediators of inflammation, but they do not address the underlying alterations in the gut microbiota that may be driving the inflammation in the first place, leaving a need for safe approaches that address this aspect of the disease.

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“To our knowledge, VE202 is the first drug candidate based on a rationally-defined bacterial consortium to enter the clinic for an autoimmune disease.”

VE202 is an orally-administered drug that comprises a rationally-defined consortium of regulatory T cell-inducing bacteria and a defined consortium of live bacteria designed to modulate the activity of regulatory T cells.

IBD is said to result from interactions between genetic factors and environmental triggers, such as commensal bacteria with pathogenic potential, and is estimated to affect more than one million people in the US.

As many as 70,000 new cases of the disease are diagnosed every year.