Phase 2 Study of V565, Anti-TNF Antibody, in Crohn’s Patients Begins

Phase 2 Study of V565, Anti-TNF Antibody, in Crohn’s Patients Begins
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-antagon
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