BURLINGTON, Mass., April 29, 2015 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Department of Defense ("DoD") awarded the company a grant1 worth approximately $2 million to conduct a Phase 2 clinical trial investigating FX006 as treatment for osteoarthritis ("OA") pain in active military and medically retired veterans with post-traumatic OA of the knee. FX006 is a steroid, triamcinolone acetonide or TCA, formulated for sustained-release, delivered by intra-articular ("IA" or "in the joint") injection for patients with OA pain of the knee. Flexion announced in February that dosing had begun in a Phase 3 clinical trial of FX006 as a treatment for pain associated with OA of the knee.
"We are pleased that the U.S. DoD has awarded Flexion a grant to study FX006 in military personnel and veterans who have experienced trauma to the knee and are looking for potentially better options to manage pain related to their knee OA," said Michael Clayman, M.D., Flexion Therapeutics' President and Chief Executive Officer. "We are honored to be working toward meeting the medical needs of our U.S. soldiers and to have the agency's support to further investigate our lead drug candidate in this capacity."
The DoD-funded trial is a single-center, double-blind, randomized, parallel group, proof-of-concept study, which plans to enroll a total of 124 male and female active and former service members between the ages of 20 and 45 years. The primary objective of this study will be to assess the analgesic effect of a single IA injection of 40 mg of FX006 relative to commercially available immediate-release TCA in active military and medically retired patients with moderately symptomatic post-traumatic OA of the knee. The primary endpoint is the average change from baseline in the weekly mean of the average daily (24-hour) pain intensity scores over weeks 5 to 10. The study is also designed to assess the effect of FX006 on function, responder status, global impressions of change, stiffness and consumption of analgesic medications and to assess the safety and tolerability of a single IA injection of 40 mg FX006 relative to commercially available immediate-release TCA.
About FX006
FX006 is a first-in-class injectable, sustained-release, IA steroid treatment for patients with moderate to severe OA pain. FX006 was specifically designed to address the limitations of current IA therapies by providing long-lasting, local analgesia while avoiding systemic side effects. To date, over 440 patients have been treated with FX006. In a completed Phase 2b dose-ranging clinical trial, FX006 has demonstrated clinically meaningful and significantly better pain relief compared to the current injectable standard of care, TCA. In two Phase 2a synovial fluid pharmacokinetic studies, a single IA injection of FX006 demonstrated therapeutic concentrations of drug in joint fluid for at least 12 weeks. FX006 is currently being studied in pivotal Phase 2b and Phase 3 clinical trials, which are designed to provide the required data for FX006 to be submitted for regulatory approval by the U.S. Food and Drug Administration.
About Flexion Therapeutics
Flexion is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel pain therapies. The company is currently advancing a portfolio of local, injectable drug candidates that have the potential to provide better and more persistent analgesia compared with existing therapy. The company's lead program, FX006, is an intra-articular sustained-release steroid in development for patients with moderate to severe OA pain. The company also has two additional product candidates, FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage OA patients.
Forward-Looking Statements
Statements in this press release regarding matters that are not historical facts, including statements relating to the future of Flexion, its ongoing development of its product candidates, potential benefits of FX006, including for treatment for pain associated with OA of the knee, the enrollment and completion of the DOD-funded Phase 2 trial, and other milestones (including the timing of such milestones) are forward-looking statements. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics, whether the company's patents will be held valid and enforceable, the fact that Flexion relies on third parties to manufacture and conduct the clinical trials of its product candidates, which could delay or limit their future development or regulatory approval, the possibility that future trial results may not be consistent with past results, the fact that Flexion will require additional capital, including prior to commercialization of FX006 and completing clinical development of any of our other product candidates and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to it, and other risks and uncertainties described in Flexion's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Flexion's Annual Report on Form 10-K for the year ended December 31, 2014 and subsequent filings with the SEC. You are encouraged to read Flexion's filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements.
1United States Army Medical Research Acquisition Activity (USAMRAA); Grant# W81XWH-13-2-0044; A Novel Intra-articular Sustained Release Steroid for Treatment of OA Pain (Phase 2 Clinical Study)