Vedanta Biosciences Publishes Phase 1a/1b Results for Lead Program VE303 in Cell Host & Microbe and Highlights Planned Presentations of Phase 2 VE303 Results

Full Phase 1 data analysis of VE303, a defined bacterial consortium candidate for C. difficile infection, published in Cell Host & Microbe

Positive topline Phase 2 results for VE303 announced in 2021; Phase 3 preparations underway

Acceptance of three abstracts for podium presentations at Digestive Disease Week 2022

Excerpt from the Press Release:

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Vedanta Biosciences, a leading clinical-stage company developing a potential new category of oral therapies based on defined bacterial consortia, today announced the publication in the journal Cell Host & Microbe of the results from a Phase 1a/1b study evaluating the safety, tolerability, and colonization dynamics of VE303 in healthy adults. VE303 is a potential first-in-class defined bacterial consortium candidate for the prevention of recurrent Clostridium difficile infection (CDI). The company will also share three research updates across its VE303 and VE202 (for inflammatory bowel disease) programs in podium presentations at Digestive Disease Week in May 2022.

“In this publication of our Phase 1 results, we show that we were able to precisely quantify the colonization dynamics of microbiome-directed agents based on defined bacterial consortia, such as VE303, and identify key factors that drive better colonization,” said Bernat Olle, Ph.D., Co-Founder and Chief Executive Officer of Vedanta Biosciences. Colonization dynamics are analogous to traditional drug pharmacokinetics and refer to the growth and persistence over time of bacterial strain populations in the human gut.

“This allows us to quantitatively describe the relationship between drug exposure and effect, which may enable optimized treatment regimens and rational analysis of clinical data. This predictability is missing from older approaches that rely on human donors, as the dose and identity of bacterial species vary widely with each fecal donation,” continued Dr. Olle. “In our subsequent Phase 2 study of VE303 in CDI, we showed that better colonization correlates with greater likelihood of sustained clinical cure. Together, we believe these results offer a more rational path forward for clinical development of microbiome-directed medicines.”

Phase 1a/1b study results
The Cell Host & Microbe paper, “Colonization of the Live Biotherapeutic Product VE303 and Modulation of the Microbiota and Metabolites in Healthy Volunteers,” details the results of a first-in-human Phase 1a/1b dose-escalation study of VE303 in healthy adults. VE303 was observed to be generally well-tolerated at all doses tested and to colonize optimally if dosed over multiple days after vancomycin pretreatment.

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