A new osteoarthritis drug being developed by Flexion Therapeutics showed significant pain relief over a placebo in a Phase II clinical study, according to the company. The anti-inflammatory drug candidate, called FX005, is directly injected into the knee and resulted in prolonged improvement in joint pain and function.
Flexion said these are the first-ever clinical results demonstrating the efficacy of a p38 MAP kinase inhibitor in osteoarthritis patients. The 12-week trial included 104 patients who were randomly assigned to receive FX005 or a placebo via intra-articular injection. The company plans to present the study results 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.”
Osteoarthritis affects more than 27 million Americans and over 100 million people worldwide. Pain relievers currently taken orally or through intra-articular injection work for only limited periods or have side effects.
“What makes this drug unique is that it is a medication that works locally in the joint, being deposited within the joint, rather than systemically,” said Daniel Bennett, MD, DABPM, a Denver pain physician who is the Chief Medical Officer of American News Report. However, Bennett cautions that Phase II proof-of-concept trials are preliminary and more data is needed to prove that FX005 works.
“In the long run, this molecule may be no better than traditional treatment. However, the results do appear promising,” said Bennett.
Flexion says there are over 50 million intra-articular injections per year worldwide with sales in excess of $1.5 billion a year. In addition to relieving pain, the company says FX005 has the potential to modify the progression of osteoarthritis.
“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,” said Michael Clayman, MD, who is CEO of Flexion. Clayman says the next phase of development for FX005 will be a Phase II dose-ranging study that will begin in the first half of 2013. Data from that study will then be used to identify an optimal dose for a Phase III study.