Biotie reports positive top-line data from clinical study with VAP-1 antibody in rheumatoid arthritis patients

20-Jan-2010 - Finland

Biotie reported that it has successfully completed a clinical trial with its fully human VAP-1 monoclonal antibody (BTT-1023) in rheumatoid arthritis patients.

The study evaluated the safety, tolerability, and pharmacokinetics of repeated doses of intravenously administered antibody in 24 rheumatoid arthritis patients with an inadequate treatment response to methotrexate. The antibody, administered at repeated doses of up to 8 mg/kg in combination with methotrexate, was generally well tolerated, and no serious or severe adverse events were reported in the study subjects. The pharmacokinetic characteristics of BTT-1023 are consistent with those expected for an intravenously administered monoclonal antibody intended for chronic conditions.

The study was not designed to enable formal statistical evaluation of therapeutic activity. However, in several assessments of treatment effect such as Disease Activity Score based on 28 joint assessment (DAS28) criteria, American College of Rheumatology (ACR) criteria, physician's global assessment and erythrocyte sedimentation rate, responses in higher dose groups were greater than in the placebo group. Several patients receiving higher doses of BTT-1023 reached an ACR50 response (i.e. a 50% reduction in their ACR score) during treatment.

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