Vedanta Biosciences enrols first patient in VE416 phase 1b/2 food allergy clinical study

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.”

Source: Company Press Release