VAP-1 Antibody product profile
A key factor in establishing – and maintaining – chronic infl ammation is the excessive accumulation of white blood cells, or leukocytes, in the tissue (e.g. surrounding joints, or in skin). Leukocytes exit the blood stream and move towards the site of infl ammation through a series of processes, including attachment to specifi cadhesion proteins. These proteins are often expressed in response to initial infl ammatory signals. Biotie has developed a fully human antibody that directly inhibits one such adhesion molecule – vascular adhesion protein-1 (VAP-1). An exciting feature of VAP-1 is that its expression is thought to be upregulated only at the site of infl ammation, limiting potential side effects of a product targeting VAP-1.
Collaboration partner
Biotie has licensed the rights to develop and commercialize its VAP-1 antibody in Japan, Taiwan, Singapore, New Zealand and Australia, to Seikagaku Corporation. Biotie could receive up to USD 16.7 million in milestone payments plus royalties on sales in these territories.
Clinical trial status
Biotie has previously completed a fi rst-in-man, single dose, placebo-controlled clinical study with VAP-1 antibody in 29 healthy volunteers. The product was generally well tolerated and no serious adverse events were reported. Development activity for VAP-1 has continued steadily throughout 2009 and in the spring, Biotie commenced two Phase Ib studies in patients to establish a basis for designing full-scale therapeutic studies and provide initial information on the therapeutic potential of the antibody.
The first trial, in rheumatoid arthritis patients, started in February and was designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of intravenously administered antibody. Assessments of therapeutic activity were included as secondary outcome measures. A similarly designed companion study in psoriasis patients started in March 2009.
In January, 2010 Biotie reported positive top-line data from the clinical study with VAP-1 antibody in rheumatoid arthritis patients. Data from the psoriasis trial is expected still in the first half of 2010.
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Updated April, 2010