Biotie Reports Positive Top-Line Results From RA Study

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 8mg/kg in combination with methotrexate, was generally well tolerated and no serious or severe adverse events were reported in the study subjects.

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 (a 50% reduction in their ACR score) during treatment.

Timo Veromaa, president and CEO of Biotie Therapies, said: “We are very pleased with the good tolerability and pharmacokinetic profile that we saw with BTT-1023 in this study. These data, combined with signals of therapeutic activity, provide, in our opinion, a good basis for proceeding into larger therapeutic trials with BTT-1023. We plan to analyze and discuss these data with our partner, Roche, to establish the optimal way to continue the clinical development program. We expect a decision from Roche, regarding its option right to in-license BTT-1023 at this stage of development, during the first half of 2010.”