Vedanta Biosciences, which was founded by PureTech Health, has commenced a phase 2 study of its rationally-defined bacterial consortium product candidate, VE303, for recurrent Clostridium difficile infection (rCDI).
VE303 is claimed to be the first drug featuring a rationally-defined bacterial consortium to advance to phase 2 study.
The earlier announced phase 1a/1b study showed rapid, durable, dose-dependent colonization and accelerated gut microbiota restoration after antibiotics.
VE303, which is produced from pure and clonal bacterial cell banks, includes a defined consortium of live bacteria designed to restore colonization resistance against gut pathogens such as C. difficile.
In 2017, Vedanta secured orphan drug designation from the US Food and Drug Administration (FDA) to prevent rCDI.
The multi-center, randomized, double-blind and placebo-controlled consortium trial will assess the safety and efficacy of two doses of VE303 compared against placebo in patients with rCDI.
Vedanta will recruit up to 146 patients in the trial, including patients completed recent diagnosis of rCDI confirmed with Clostridium difficile toxin assay. It will also include patients completing a course of antibiotics but remain at risk for recurrence.
According to the company, the primary endpoint of the study will be prevention of infection recurrence at eight weeks.
Dose selection for the current study was based on the results of a recently completed phase 1a/1b study of VE303 in healthy volunteers.
The phase 1 study has demonstrated that VE303 treatment enhanced the restoration of gut microbiota after a course of antibiotics.
Vedanta Biosciences co-founder and CEO Dr Bernat Olle said: “This is the first Phase 2 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.
Other microbiome-derived product candidates of the company include VE202, VE416 and VE800.
Vedanta, along with Janssen Biotech, intends to start phase 1 study of VE202 to treat inflammatory bowel disease (IBD).
It also intends to begin a phase 1/2 study of VE416 in food allergy in the first quarter of 2019 and the phase 1/2 study of VE800 and Opdivo (nivolumab) in advanced or metastatic cancers in mid-2019