Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) today announced the acceptance of two Phase 1 data presentations on SBI-087 (PF-05230895) at the 2010 annual congress of the European League Against Rheumatism (EULAR) in Rome, Italy. Presentations will include promising data from a Phase 1 study of SBI-087 for the treatment of rheumatoid arthritis (RA) and a Phase 1 study of SBI-087 for the treatment of systemic lupus erythematosus (SLE). Copies of both abstracts are available at http://www.eular.org. SBI-087 is Trubion's next-generation CD20-directed small modular immunopharmaceutical (SMIP™) product candidate and is being developed in collaboration with Pfizer.
Abstract OP0053: Subcutaneous (SC) administration of SBI-087 provides potent B-cell depletion in subjects with controlled RA | |
Oral Presentation | |
June 17, 2010; 10:30 a.m.–Noon | |
Room 8 B | |
Roy Fleischmann | |
The Phase 1 trial was designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ascending single doses of SBI-087 in patients with controlled RA. At the time of the abstract submission, 60 patients enrolled in the open-label Phase 1 trial had received intravenous doses of SBI-087 ranging from 0.15 to 2 mg/kg or subcutaneous doses of 50, 100, 200 and 300 mg. All of the patients studied had well-controlled RA. Data demonstrate that SBI-087, given as a single subcutaneous dose with a day-of-treatment oral steroid regimen, is generally well-tolerated and induces potent B-cell depletion. The most frequently reported adverse events were upper respiratory infection, headache, diarrhea, chills, fever, fatigue and bruising at the injection site. SBI-087 administered at subcutaneous doses of at least 100 mg depleted peripheral blood B-cell levels to less than 5 cells/uL for at least 12 weeks. Trubion's collaboration partner, Pfizer, initiated a Phase 2 study of SBI-087 for RA in January to evaluate safety and efficacy of SBI-087. The 200 mg subcutaneous dose was selected to be further investigated as part of this trial. Abstract SAT0188: B-cell depletion in subjects with controlled systemic lupus erythematosus (SLE) after intravenous or subcutaneous administration of SBI-087 | | Poster Presentation | | June 19, 2010; 10:15–Noon | | Fiera Roma – Poster Areas in Halls 5 & 6 | |
At the time of abstract submission, data was available for 18 patients enrolled in an open-label Phase 1 study of SBI-087 for SLE. Patients received intravenous doses of 0.5 mg/kg or subcutaneous doses of 25 mg or 75 mg of SBI-087. All patients had well-controlled SLE. Preliminary data demonstrate that SBI-087 was generally well-tolerated by patients with well-controlled lupus when administered as a single subcutaneous dose with a day-of-treatment oral steroid regimen. Adverse events included chills, extreme fatigue, upper respiratory tract infection and muscle spasms. Subcutaneous doses of 75 mg of SBI-087 depleted peripheral blood B-cell levels in all subjects to below 20 cells/uL. Five of six subjects in this cohort had B-cell levels below 5 cells/uL by week two. By week 10, B-cell levels increased to above 20 cells/uL in four of six subjects. The Phase 1 trial is ongoing and is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ascending single doses of SBI-087 in patients with controlled SLE. "Data to be presented at EULAR reinforce the need for differentiated treatments for RA and SLE," said Scott Stromatt, M.D., chief medical officer of Trubion. "We look forward to continued evaluation of our second generation CD20 compound and further defining its role in the treatment of RA and SLE." |
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