Abstract

Abstract Inflammatory Bowel Disease, which is comprised of Crohn’s disease (CD) and ulcerative colitis (UC), are chronic and debilitating diseases. Traditional therapies, which consist of anti-inflammatories and immunomodulators, are palliative at best and do not alter the progressive course of the disease. Advances in the understanding IBD pathology have led to new therapeutic strategies that are centered around targeted biologics to significantly alter disease progression. Although these targeted biologics demonstrate significant improvements in the quality of life for patients, systemic administration can have significant negative side effects such as risk of infection and malignancies. Ventria Bioscience utilizes a nonanimal-based expression system known as ExpressTec to express at commercially viable levels a recombinant human milk protein that has potent anti-inflammatory activity. This protein, known as VEN-α, exhibits a protective effect when T84 monolayers are exposed to proinflammatory cytokines TNF-alpha and Interferon-gamma in the presence of VEN-α in vitro. Further, when orally delivered once daily to mice subjected to DSS treatment ad libitum, VEN-α improves clinical and histopathological outcomes that is comparable to cyclosporin. Oral delivery of VEN-α may reduce unwanted effects associated with systemic administration and at the same time concentrate the active biologic at the site of pathology. Future studies planned will focus on further detailing efficacy in other models of IBD and understanding the pharmacokinetic profile of this orally delivered biologic. However, collectively the data to date suggests the orally delivered VEN-α has potential as a novel targeted biologic in the treatment of IBD.

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