Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) announced that its collaboration partner, Pfizer, has initiated a Phase 2 clinical trial of SBI-087 (PF-05230895) for the treatment of rheumatoid arthritis (RA). SBI-087 is a next-generation, humanized Small Modular ImmunoPharmaceutical (SMIP(TM)) protein therapeutic directed against the CD20 antigen. SBI-087 is also being evaluated in Phase 1 clinical trials for RA and systemic lupus erythematosus (SLE).
The Phase 2 multi-center, randomized, placebo-controlled, double-blind, parallel-group, outpatient dose regimen-finding study will enroll approximately 200 patients who meet the criteria for RA with American College of Rheumatology (ACR) Functional class I, II or III, are seropositive, and who have been diagnosed with RA more than six months before trial initiation. Participants will be randomly assigned to receive either placebo or one of four SBI-087 dosing regimens. This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active RA, who are on a stable dose of methotrexate. The primary outcome measure will include responses based on the ACR criteria (ACR 20 response).
"Initiating the Phase 2 trial of SBI-087 for RA is an important milestone for Trubion," said Scott Stromatt, M.D., senior vice president and chief medical officer of Trubion. "We look forward to evaluation of our next-generation CD20 compound in a larger patient population and further definition of its role in helping Trubion to establish category leadership in autoimmune and inflammatory diseases."
About Trubion
Trubion is a biopharmaceutical company that is creating a pipeline of novel protein therapeutic product candidates to treat autoimmune and inflammatory diseases and cancer. The Company's mission is to develop a variety of first-in-class and best-in-class product candidates, customized for optimal safety, efficacy and convenience that it believes may offer improved patient experiences. Trubion's current product candidates are novel single-chain protein, or SMIP, therapeutics, and are designed using its custom drug assembly technology. Trubion's product pipeline includes CD20-directed SMIP therapeutics such as TRU-015 and SBI-087 for autoimmune and inflammatory diseases, developed under the Company's Pfizer collaboration. Trubion's product pipeline also includes TRU-016, a novel CD37-targeted therapy for the treatment of B-cell malignancies developed under the company's Facet collaboration. In addition to Trubion's current clinical stage product pipeline, the Company is also developing its multi-specific SCORPION technology, both for targeting cell-surface molecules like CD79b and HLA-DR, as well simultaneously neutralizing soluble ligands like TNF and IL-6.
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