Trubion Pharmaceuticals, a biopharmaceutical company, has announced that its collaboration partner Wyeth Pharmaceuticals, a division of Wyeth, has initiated a Phase I clinical trial of SBI-087, Trubion’s next generation CD20 drug candidate, for the treatment of systemic lupus erythematosus.
The Phase I SBI-087 dose escalation clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous or intravenous dose of SBI-087 in patients with systemic lupus erythematosus (SLE). The study will enroll patients who were diagnosed with SLE, based on the American College of Rheumatology Revised Criteria, more than six months prior to study initiation.
According to Trubion, preclinical data demonstrated that a single dose of SBI-087 resulted in more potent B-cell depletion in peripheral blood and lymphoid tissues than rituximab.
The objective of the preclinical study conducted by Wyeth was to evaluate the pharmacokinetics and pharmacodynamics of SBI-087 following a single intravenous dose. Administration of SBI-087 resulted in dose-dependent B-lymphocyte depletion in peripheral blood and lymphoid tissues that was more profound and sustained in SBI-087-treated groups compared with rituximab.
Based on Trubion’s small modular immunopharmaceutical technology, SBI-087 is also being evaluated in a Phase I clinical trial for rheumatoid arthritis.
Peter Thompson, president and CEO of Trubion, said: Initiation of the SBI-087 Phase I SLE clinical trial marks another important milestone in advancing our products developed in collaboration with Wyeth. We believe that SBI-087, along with our lead candidate TRU-015, have the potential to play an important role in improving patient care and helping us establish category leadership in autoimmune and inflammatory disease markets.