Vedanta Biosciences Announces First Patient Enrolled in VE416 Phase 1b/2 Food Allergy Clinical Study

First clinical study of a rationally-defined bacterial consortium (VE416) for treating food allergy, will initially be studied in patients with history of peanut allergy

Antigen-agnostic approach could potentially be used to address multiple food allergies

CAMBRIDGE, Mass., July 1, 2019Vedanta Biosciences, a clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiota-derived bacteria, today announced the first patient has been enrolled in the Phase 1b/2 clinical study of VE416 in adults and adolescents with a history of peanut allergy. VE416 is Vedanta Biosciences’ live biotherapeutic product candidate being developed for treatment of food allergies, including persistent peanut allergy.

The study, which is being conducted at MassGeneral Hospital for Children, will explore VE416 as a monotherapy, and in combination with an oral peanut immunotherapy, over the course of several months. The randomized, double-blind, placebo-controlled trial is slated to enroll up to 40 patients that are 12 years of age and older. The primary endpoints are safety of VE416 and amount of peanut protein tolerated during a double-blind, placebo-controlled food challenge following the treatment.

“Food allergies are both common and devastating, and we have evidence that the microbiome plays an important role,” said Wayne Shreffler, M.D., Ph.D., chief of pediatric allergy and immunology and director of the Food Allergy Center at Massachusetts General Hospital. “People with food allergies are keenly interested in more options than avoidance. I’m hopeful that modulating the gut ecosystem with therapeutics derived from the microbiome may prove to be a safe and effective tool by itself or a way to improve allergen desensitization.”

The clinical trial of VE416 draws on previous work conducted by Vedanta Biosciences and its scientific co-founder, Dr. Kenya Honda at Keio University, to identify gut bacteria that can induce immunoregulatory responses and protect against allergic intestinal disease. This research and independent findings show that these immunoregulatory bacteria can potentially have protective effects against a range of food allergens, suggesting they work via antigen-agnostic mechanisms. 

“There has been a marked increase in the prevalence of food allergies in industrialized societies over the last few decades, and while there is no single explanation for why that is the case, multiple lines of evidence point to the effects of modern lifestyle practices on the gut microbiota,” said Bernat Olle, Ph.D., co-founder and chief executive officer of Vedanta Biosciences. “We are excited to start the first study to examine the potential benefits of a rationally-defined bacterial consortium for treatment of peanut allergic patients.”

About VE416

VE416 is an orally administered investigational live biotherapeutic product (LBP) consisting of a defined bacterial consortium. It is produced from pure, clonal bacterial cell banks, which yield a drug product of uniform composition in powdered form and free of any pathogenic strains, bypassing the need to rely on fecal donor material with inconsistent composition. In preclinical research, VE416 induced protective immunoregulatory responses and reduced anaphylaxis and allergic symptoms in sensitized mice. The VE416 Ph1b/2 study will enroll 40 peanut allergic patients ages 12 and older, including individuals with single and multiple food allergies. The study will assess the safety and colonization of VE416 and the amount of peanut protein tolerated following treatment. The study will also assess the efficacy of VE416 in inducing higher rates of clinical tolerance and reducing adverse effects in patients undergoing peanut oral immunotherapy.

About Vedanta Biosciences

Vedanta Biosciences is a clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria. Vedanta Biosciences is a leader in the microbiome field with capabilities and deep expertise to discover, develop, and manufacture live bacteria drugs. These include what is believed to be the largest collection of human-gut associated bacteria, a suite of proprietary assays to select pharmacologically potent strains, vast proprietary 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 programs in infectious disease, autoimmune disease, allergy, and immuno-oncology.

Vedanta Biosciences was founded by PureTech Health (LSE: PRTC). Its scientific co-founders are world-renowned experts in immunology and microbiology who have pioneered the fields of innate immunity, Th17 and regulatory T cell biology, and include Ruslan Medzhitov, Ph.D., (Yale and Howard Hughes Medical Institute (HHMI)), Brett Finlay, Ph.D., (University of British Columbia and HHMI), Kenya Honda, Ph.D., (Keio University and RIKEN), Dan Littman, Ph.D., (New York University and HHMI), Alexander Rudensky, Ph.D., (Sloan Kettering and HHMI), and Jeremiah Faith, Ph.D., (Mount Sinai School of Medicine).

Forward Looking Statement

This press release contains statements that are or may be forward-looking statements, including statements that relate to the company's future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.




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