Flexion Therapeutics Offers Final FX006 Data from Closed Phase 2b Dose-Ranging Trial at JBJS

Flexion Therapeutics, Inc. FLXN today announced that a manuscript describing final study results from a completed Phase 2b clinical trial of FX006, an intra-articular (IA) sustained release corticosteroid for the treatment of osteoarthritis (OA), has been published online1 in the Journal of Bone and Joint Surgery (JBJS). The results demonstrate that FX006 provides superior pain relief to the current standard of care in the treatment of OA of the knee. OA of all joints afflicts more than 27 million adults in the U.S. and 100 million worldwide. Flexion is currently studying FX006 in a Phase 3 clinical trial as a treatment for pain associated with OA of the knee as well as in a Phase 2 clinical trial as a potential treatment for OA pain in active military and medically retired veterans with post-traumatic OA of the knee. Michael Clayman, M.D., Flexion Therapeutics' President and Chief Executive Officer, said, "The publication of our Phase 2b trial results helps to provide important information on FX006 to the medical community, increasing awareness of FX006 as a first-in-class injectable, sustained-release, IA steroid. We are excited about the potential for FX006 and believe it can make a real difference for the many patients who suffer from OA knee pain and are enthusiastically advancing this product." The clinical trial described in the JBJS manuscript was conducted in the United States, Canada and Australia. Researchers enrolled 228 patients with moderate to severe OA of the knee. Patients were injected with immediate-release triamcinolone acetonide (TCA) (the standard of care) or 10, 40 or 60 mg of study drug FX006. The primary outcome measure was the weekly mean of the average daily pain intensity score assessed using an 11-point numerical rating scale (NRS) where 0 represents no pain and 10 represents the worst pain imaginable. At the 8-week endpoint, the 40 mg dose of FX006 demonstrated a statistically (p= 0.01) and clinically significant improvement relative to immediate-release TCA, and analyses of secondary measures including Western Ontario and McMaster Universities (WOMAC®) pain, stiffness, and function subscales, patient global impression of change and clinician global impression of change also demonstrated statistical superiority. Additionally, the 40 mg dose of FX006 produced pain relief that was improved at Weeks 2-12 and statistically superior to immediate-release TCA at weeks 5-10 (p<0.05 at each time point), and the time-weighted average of pain relief (assessed with NRS intensity scores) was statistically superior to immediate-release TCA over Weeks 1-12 (p=0.04). In summary, the extended residency of drug in the joint with 40 mg of FX006 not only prolonged but also amplified analgesic effect relative to the standard of care. Neil Bodick, M.D., PhD., Flexion Therapeutics' Chief Medical Officer, noted, "The Journal of Bone and Joint Surgery is among the most highly regarded publications with orthopedists and sports medicine physicians, who are key decision makers in the management of OA patients. These specialists perform approximately 70 percent of all intra-articular knee injections in this patient population."