Biotie has started a clinical trial with its fully human VAP-1 monoclonal antibody (BTT-1023) in rheumatoid arthritis patients.

TURKU, Finland | February 17, 2009 | Biotie has started a clinical trial with its fully human VAP-1 monoclonal antibody (BTT-1023) in rheumatoid arthritis patients.

The study will be conducted within the European Union and will evaluate the safety, tolerability, and pharmacokinetics of repeated doses of intravenously administered antibody in up to 36 patients with rheumatoid arthritis. The results are expected in the first half of 2010, and are expected to establish a basis for designing full-scale therapeutic studies and provide initial information on the therapeutic potential of the antibody. A similarly designed clinical study in psoriasis patients is expected to start by the end of Q1/2009.

Biotie and Roche have signed an option agreement for the antibody program targeting VAP-1. Under the terms of the agreement, Roche has paid an option initiation fee of EUR 5 million, which grants Roche an exclusive option right to an exclusive, worldwide license agreement for Biotie’s fully human antibody targeting VAP-1, excluding Japan, Taiwan, Singapore, New Zealand, and Australia. The initial option right will end upon completion of Phase I, and it is expected that this point will be reached when the currently starting study is completed. Roche may extend the option right to later development points by paying additional fees. Biotie will retain all rights to the program until a license is granted to Roche.

Inhibiting VAP-1 reduces inflammation by regulating the migration of leukocytes, or white blood cells, to inflamed tissues.

SOURCE: Biotie Therapies Corp.