VHsquared announced the first patients have entered HARBOR, an international Phase 2 clinical trial examining the efficacy of V565 ( an anti-TNFα oral antibody) in treating Crohn’s disease. The study is currently recruiting patients.
HARBOR is a randomized, double-blind and placebo-controlled study (NCT02976129) investigating the efficacy, safety, and tolerability of six weeks treatment with V565 in more that 100 subjects with moderately to severely active Crohn’s disease.
The trial’s primary outcome is the proportion of patients responding to the treatment at day 42, assessed by changes in clinical symptoms, as measured by the Crohn’s Disease Activity Index (CDAI) and inflammatory markers.
HARBOR follows a four-part Phase 1 trial (NCT03010787), that evaluated V565 in patients with Crohn’s disease and in healthy patients with a terminal ileostomy.
Results showed that the drug was safe and well-tolerated at high single and multiple doses, with minimal systemic exposure and no drug-induced antibodies. This trial also confirmed that high concentrations of active V565 were delivered throughout the gastrointestinal tract of participants.
V565 is a modified antibody that blocks a mediator of inflammation called TNF, known to be produced excessively in Crohn’s disease (CD). TNF causes inflammation of the bowel, and blocking this molecule underlies the therapeutic effect of TNF-antagonists in CD. Unlike licensed TNF antagonists, V565 can be administered orally and is not generally absorbed into the circulation.
“Inflammatory bowel diseases are debilitating conditions in clear need of new therapeutic approaches, so I’m delighted to be involved in this exciting trial. 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, said in a press release.
Rod Richards, CEO of VHsquared said, “Following on from the successful Phase I trial of our lead product, V565, we are pleased to have progressed rapidly to Phase II trial enrolment. We believe that V565 offers a transformational approach to the treatment of IBD, with oral delivery of the Vorabody achieving a highly desirable clinical impact.”