22 May 2019 - - US-based clinical-stage company Vedanta Biosciences has presented expanded, long-term positive data from its Phase 1a/1b study of VE303, the company's lead, orally-administered live biotherapeutic product candidate for recurrent Clostridium difficile infection, the company said.

The data were presented at Digestive Disease Week 2019, held in San Diego, California, and supports the dosing employed in the ongoing Phase 2 study of VE303 and further illuminate interactions between VE303 and gut microbiota.

The expanded data build on the preliminary results of the Phase 1a/1b study previously disclosed by the company, which found that all doses of VE303 were safe and well-tolerated and that treatment with VE303 resulted in rapid, durable, and dose-dependent colonisation of VE303 strains across a heterogenous group of 23 adults.

The study also found that VE303 treatment accelerated the restoration of gut microbiota after a course of antibiotics.

In late 2018, Vedanta announced the initiation of a Phase 2, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of two doses of VE303 compared to placebo in patients with rCDI.

The study is expected to enroll up to 146 patients with a recent diagnosis of rCDI, confirmed using a Clostridium difficile toxin assay, and who have completed a course of antibiotics but remain at risk for recurrence. The primary endpoint will be prevention of infection recurrence at eight weeks.

VE303 is a first-in-class orally-administered investigational live biotherapeutic product consisting of a defined bacterial consortium.

It is produced under GMP conditions from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypasses the need to rely on direct sourcing of fecal donor material of inconsistent composition.

VE303 is designed to restore colonisation resistance against gut pathogens, including C. difficile, after treatment with antibiotics.

In 2017, Vedanta Biosciences received a USD 5.4m research grant from CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator) to support clinical studies of VE303.

VE303 was granted Orphan Drug Designation in 2017 by the United States Food and Drug Administration for the prevention of recurrent C. difficile infection and is currently being evaluated in a Phase 2 clinical study for the treatment of rCDI.

Vedanta Biosciences is a clinical-stage microbiome leader developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria.

Vedanta's proprietary capabilities include what is believed to be the largest collection of human-gut associated bacteria, assays and bioinformatics techniques for consortia design and optimisation, vast datasets from human interventional studies and facilities for cGMP-compliant manufacturing of rationally-defined bacterial consortia in powder form.

Vedanta Biosciences' pioneering work, in collaboration with its scientific co-founders, has led to the identification of human commensal bacteria that induce a range of immune responses including induction of regulatory T cells, CD8+ T cells, and Th17 cells, among others.

These advances have been published in leading peer-reviewed journals, including Science (multiple), Nature (2013, 2019), Cell, and Nature Immunology. Vedanta Biosciences has harnessed these biological insights and its capabilities to generate a pipeline of investigational live biotherapeutic products in infectious disease, autoimmune disease, allergy, and immuno-oncology.

This pipeline includes 2 clinical-stage product candidates currently being evaluated for the treatment of recurrent C. difficile infection and inflammatory bowel disease (in collaboration with Janssen Biotech, Inc.) as well as two additional product candidates entering the clinic in 2019 in food allergy and in patients with advanced or metastatic cancers (in combination with Bristol-Myers Squibb's checkpoint inhibitor OPDIVO).

Vedanta's IP portfolio contains 20 US patents and numerous foreign issuances with coverage extending to 2037.

Earlier this year, the European Patent Office upheld Vedanta's foundational Honda Patent, which is now issued in major commercial markets, including the United States, Europe, and Japan. Vedanta Biosciences was founded by PureTech Health(LSE.PRTC).

Its scientific co-founders are experts in immunology and microbiology who have pioneered the fields of innate immunity, Th17 and regulatory T cell biology.