3 July 2019 - - 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, US-based clinical-stage company Vedanta Biosciences said.
VE416 is Vedanta Biosciences' live biotherapeutic product candidate being developed for treatment of food allergies, including persistent peanut allergy.
This 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 randomised, 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.
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.
VE416 is an orally administered investigational live biotherapeutic product 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.
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 was founded by PureTech Health (LSE: PRTC).