VE303 is being developed as a treatment for clostridium difficile infection. Credit: Sanofi Pasteur.

Vedanta Biosciences has commenced a Phase II trial to investigate the safety and efficacy of VE303 in comparison with placebo for the treatment of patients with recurrent clostridium difficile infection (rCDI).

VE303 is currently under development as an orally-administered live biotherapeutic product (LBP).

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Vedanta aims to assess two doses of VE303 as part of the double-blind, placebo-controlled consortium trial.

Both doses were selected on the basis of a newly completed Phase Ia/Ib trial of VE303 in healthy volunteers.

The multi-centre, randomised Phase II trial intends to include up to 146 rCDI patients recently diagnosed and who have completed an antibiotics course but remain at risk for recurrence.

“This is the first Phase II study, to our knowledge, of a rationally-defined bacterial consortium candidate in any indication.”

Primary endpoint of the trial includes prevention of infection recurrence at eight weeks.

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Vedanta Biosciences co-founder and CEO Bernat Olle said: “This is the first Phase II study, to our knowledge, of a rationally-defined bacterial consortium candidate in any indication, so it represents a major milestone for Vedanta Biosciences and the field.

“Our Phase Ia/Ib study helped de-risk key questions for our modality, in particular whether robust, durable colonisation, superior to what has been reported for probiotics in the past, can be obtained with a defined consortium and whether the right consortium can rapidly restore the gut microbiota after antibiotics.”

Vedanta Biosciences recently announced a Phase I trial of VE202 for inflammatory bowel disease (IBD), in collaboration with Janssen Biotech.

The company aims to begin a Phase I/II trial of microbiome-derived product candidate VE800 in combination with opdivo (nivolumab) in advanced or metastatic cancers.