Transforming the treatment of inflammatory bowel disease
VHsquared’s oral domain antibodies combine the dramatic clinical impact of injectable antibody therapeutics in inflammatory bowel disease (IBD) with the benefits of oral administration, resulting in targeted activity, negligible systemic exposure and minimal immunogenicity. This approach represents a step change in the treatment of IBD and raises the possibility of treatment early in the course of the condition, reducing disease progression, improving quality of life and offering significant healthcare benefits.
VHsquared uses its pioneering Vorabody™ platform to generate potent protease resistant domain antibodies for oral administration. Oral delivery of these novel gut-restricted biologics – Vorabodies™ – results in optimum local concentrations directly at the required site of action in the small and large intestine. Vorabodies are identified, screened, selected and engineered for intestinal stability by VHsquared.
The company’s pipeline consists of seven complementary Vorabody products, the most advanced of which, V565, is in international Phase II clinical development for Crohn’s disease. V565 is an anti-TNFα oral domain antibody and is expected to be the first oral biologic registered for IBD. This short animation shows how V565’s unique characteristics enable it to be delivered directly to areas of active disease in the gut, where it is expected to reduce inflammation and thereby return the tissue to its healthy state.
The video is available in a range of languages, as follows:
The Phase II HARBOR study1 aims to demonstrate the efficacy of V565 as measured by changes in clinical symptoms, markers of inflammation and endoscopic appearance. It is randomised, double-blind and placebo-controlled, involving over 100 patients with moderately to severely active Crohn’s disease.
The study follows on from a positive Phase I trial which emphasised the superior profile and clinical potential of V565. The product was shown to be safe and well tolerated at high single and multiple doses, with minimal systemic exposure and no drug-induced antibodies. In addition, the trial confirmed that high concentrations of active V565 were delivered throughout the small and large intestine in volunteers and Crohn’s patients.