VE416 is an oral, live biotherapeutic product candidate that comprises a defined bacterial consortium. It is generated using clonal bacterial cell banks that are said to produce a drug product with pathogen-free composition in powdered form.
The randomised, double-blind, placebo-controlled Phase Ib/II trial will assess VE416 as a monotherapy and in combination with oral peanut immunotherapy in 40 patients aged 12 years and above with a history of peanut allergy.
Primary endpoints of the study are the drug candidate’s safety and amount of peanut protein tolerated during a double-blind, placebo-controlled food challenge after the treatment.
The trial, which is being conducted at MassGeneral Hospital for Children, will also evaluate the product’s efficacy in triggering higher clinical tolerance rates and minimising adverse effects in patients on peanut oral immunotherapy.
Vedanta Biosciences co-founder and CEO Bernat Olle said: “There has been a marked increase in the prevalence of food allergies in industrialised 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.
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“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.”
The Phase Ib/II trial builds on the company’s previous research on gut bacteria, which could stimulate immunoregulatory responses and protect from allergic intestinal disease.
According to the company, immunoregulatory bacteria could potentially exhibit protective effects against various food allergens. This is believed to indicate their antigen-agnostic mechanism of action.
PureTech Health chief scientific officer Joseph Bolen noted: “This study will be an important milestone as we seek to desensitise patients to allergens by modulating their microbiomes with a rationally defined live biotherapeutic product.”