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news.Santarus has commenced a randomized, placebo-controlled, blinded, single-center, single-dose, dose-escalation Phase I study evaluating its anti-VLA-1 antibody, SAN-300.
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The study is designed to determine the safety, efficacy, pharmacokinetics, pharmacodynamics of single doses of SAN-300.
In the trial, the company is evaluating around 60 patients including healthy volunteers and two cohorts of patients with rheumatoid arthritis.
Santarus president and CEO Gerald Proehl said they 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.
Santarus Clinical Research senior vice president Mark Totoritis said SAN-300 targets a major collagen receptor, VLA-1 (a1ß1 integrin), and has shown activity in multiple preclinical models of inflammation.