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The HARBOR study

HARBOR is a Phase II study of oral anti-TNFα domain antibody V565 in Crohn’s disease. It is taking place in North America and Europe, and aims to demonstrate the efficacy of the Vorabody V565 as measured by changes in clinical symptoms, markers of inflammation and endoscopic appearance. The trial involves over 100 patients with moderately to severely active Crohn’s disease. There is more information on the study here.

News release – First patients entered into Phase II trial of VHsquared’s lead Vorabody product V565

‘The profile of V565 offers a step change in approach to IBD management, potentially resulting in substantial disease modification early in its course, reducing progression, improving quality of life and bringing significant benefits to patients.’

Arthur Kaser MD, PD Professor of Gastroenterology at the University of Cambridge, UK

The HARBOR trial follows on from a positive Phase I trial which emphasised the differentiated 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.

Short Animation showing V565’s unique characteristics

How V565 works

V565, an orally administered  domain antibody engineered to be resistant to intestinal proteases, has been designed to achieve optimum local concentrations directly at the site of disease in the small and large intestine.  The animation here shows how it is expected to work in the treatment of Crohn’s disease.

The video is available in a range of languages, as follows:

About inflammatory bowel disease

You may find the following to be useful sources of information on IBD.

Czech Republic

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