The trial is designed to evaluate safety and clinical response rates in patients with rheumatoid arthritis. Small Modular ImmunoPharmaceutical (SMIP) drugs represent a novel class of immunotherapeutics that Trubion believes possess enhanced drug properties over monoclonal and recombinant antibodies. Trubion is developing the drug known as TRU-015 with Wyeth Pharmaceuticals.
“We are pleased with the rapid enrollment of this study and look forward to reporting its results later this year,” said Peter Thompson, president and CEO of Trubion.
“Previously reported TRU-015 clinical trial data has been promising and we expect that the results of our ongoing clinical evaluation will serve as the basis for phase III pivotal trial design.”
Similar to the phase IIa study, the phase IIb trial will evaluate composite measurements of improvement in disease activity derived from parameters such as tender and swollen joint counts, patient and physician global assessments, patient assessment of pain and disability, and laboratory measures of inflammation.