Santarus has initiated patient enrolment in the Phase IIa study designed to assess the safety and tolerability of repeat subcutaneous (SC) doses of SAN-300 in patients with active rheumatoid arthritis with inadequate response to disease-modifying anti-rheumatic drugs.
The randomised, double-blind study will enrol up to 90 patients in five groups. There is a four week follow-up period for safety and efficacy assessments.
The primary objective of the placebo-controlled, multiple ascending dose Phase IIa study is to assess the safety and tolerability of repeat doses of SAN-300 SC in patients with active RA.
Secondary objectives include pharmacokinetics and pharmacodynamics, preliminary efficacy and immunogenicity.
Planned doses of SAN-300 to be studied include 0.5mg/kg SC once weekly, 1.0mg/kg SC once weekly, 2.0mg/kg SC every other week, 2.0mg/kg SC once weekly, and 4.0mg/kg SC every other week.
All patients from each group will receive SAN-300 or placebo at their assigned dose and administration frequency for a total of six weeks.
SAN-300 is an investigational drug that is a humanised anti-VLA-1 monoclonal antibody and an inhibitor of VLA-1, also known as a1ß1 integrin.
According to Santarus, SAN-300 is a drug candidate that has potential application in multiple inflammatory and autoimmune diseases, including rheumatoid arthritis, inflammatory bowel disease, psoriasis, asthma and organ transplantation.
Santarus has already completed a Phase I clinical programme with SAN-300, which it had initiated in March 2011.
The placebo-controlled, blinded, dose-escalation study was conducted in Australia and the single-dose study enrolled approximately 60 subjects, including healthy volunteers and two cohorts of patients with rheumatoid arthritis.
Objectives of the Phase I clinical study included the assessment of safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of SAN-300.
Santarus acquired the exclusive worldwide rights to SAN-300 in September 2010, through the acquisition of closely held Covella Pharmaceuticals , and a related amended licensing agreement with Biogen Idec.
Biogen Idec has initially developed the anti-VLA-1 antibody and licensed to Covella in January 2009.
Image: X-ray of the hand in rheumatoid arthritis. Photo: courtesy of Braegel.