Flexion Therapeutics, Inc. today reported that its lead osteoarthritis drug candidate, FX005, demonstrated significant pain relief over placebo at four weeks in a Phase 2 proof-of-concept trial. Top-line data showed FX005, delivered intra-articularly to the knee, was well-tolerated and resulted in prolonged improvement in joint pain and function throughout the 12-week duration of the study. These are the first-ever clinical results demonstrating the efficacy of a p38 MAP kinase inhibitor in osteoarthritis patients. Flexion plans to present the complete data set and analyses at an upcoming medical conference.
"There is considerable unmet need for treatments for the pain and damage caused by osteoarthritis," said Timothy McAlindon, chair of rheumatology and professor of medicine at Tufts Medical Center. "In particular, physicians and patients need targeted treatments for osteoarthritis that are more effective and longer lasting. These results represent a significant advance in that direction, so we will eagerly monitor development of this new treatment."
Michael Clayman, M.D., chief executive officer of Flexion, said, "We believe these data not only demonstrate the therapeutic potential of FX005 but also validate Flexion's approach to the treatment of osteoarthritis -- intra-articular delivery of sustained-release therapies providing prolonged activity at the site of disease while minimizing systemic exposure and the corresponding risk of systemic side effects. We are enthusiastic about advancing FX005 into the next phase of clinical development, which will be a Phase 2b dose-ranging study that we plan to initiate in the first half of 2013. The data from that study will then be used to identify an optimal dose for Phase 3."
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