Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced that it has initiated a Phase I clinical study with SAN-300, its anti-VLA-1 antibody. The randomized, placebo-controlled, blinded, single-center, single-dose, dose-escalation study is being conducted in Australia in a total of approximately 60 subjects, including healthy volunteers and two cohorts of patients with rheumatoid arthritis. The objectives of the study are to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of SAN-300. The company expects to complete this Phase I clinical study with SAN-300 in the first half of 2012.
"We believe SAN-300 represents a novel approach to autoimmune and inflammatory disease therapy with potential applicability in multiple diseases, including rheumatoid arthritis, inflammatory bowel disease, psoriasis and organ transplantation," said Santarus president and chief executive officer Gerald T. Proehl.
Santarus senior vice president of clinical research Mark C. Totoritis, M.D., said, "SAN-300 targets a major collagen receptor, VLA-1 (α1β1 integrin), and has shown activity in multiple preclinical models of inflammation. This integrin, a cell adhesion molecule, plays a key role in the migration, retention and proliferation of activated T cells and monocytes at sites of chronic inflammation."
Santarus acquired the exclusive worldwide rights to SAN-300 in September 2010, through the acquisition of closely held Covella Pharmaceuticals, Inc., and a related amended license agreement with Biogen Idec. The anti-VLA-1 antibody was initially developed by Biogen Idec and licensed to Covella in January 2009.