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news.Trubion Pharmaceuticals has initiated a phase IIb clinical trial of TRU-015, the company's lead Small Modular ImmunoPharmaceutical (SMIP) drug candidate for the treatment of rheumatoid arthritis.
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Trubion is developing TRU-015 with biopharmaceutical company, Wyeth.
Upon initiation of this phase IIb study and pursuant to the terms of its collaboration with Wyeth, Trubion will receive an $8 million milestone payment and reimbursement of prior manufacturing-related costs.
“Our clinical trials so far have demonstrated that TRU-015 measurably improves the signs and symptoms of rheumatoid arthritis and we look forward to the results of our continuing clinical evaluation of TRU-015,” said Peter Thompson president and CEO of Trubion.
Similar to the phase IIa study, this study will evaluate 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 levels of inflammation.
Results of the phase IIa study showed that in the first 24 weeks after receiving infusions of TRU-015, 72% of the subjects experienced a clinical response that is equal to or greater than that required to achieve an ACR20 response. ACR20 is defined as an improvement of at least 20% from baseline in counts of both tender and swollen joints, as well as in at least three of five other disease activity parameters.