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With rapid enrollment in Phase 3 trial, the company expects to report topline data in first quarter of 2016, ahead of schedule
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Topline data from ongoing pivotal Phase 2b clinical trial also expected to be reported earlier than planned
BURLINGTON, Mass., July 29, 2015 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that it has completed enrollment of 486 patients in the Phase 3 clinical trial of its lead compound FX006 approximately three months earlier than anticipated, and the company now plans on reporting topline data from this trial in the first quarter of 2016. This study will complete the requisite clinical package for the New Drug Application (NDA) submission of FX006. The topline clinical data readout from the company's ongoing Phase 2b clinical trial is expected in September 2015, approximately two months ahead of schedule.
FX006 is Flexion's novel, non-opioid, sustained-release, intra-articular (IA) (within the joint) formulation of triamcinolone acetonide (TCA). FX006 is designed to treat patients with moderate to severe osteoarthritis (OA) pain of the knee and is intended to provide substantial and persistent pain relief while avoiding systemic side effects. OA of all joints afflicts more than 27 million adults in the U.S. and 100 million worldwide.
Michael Clayman, M.D., Flexion Therapeutics' President and Chief Executive Officer, said, "We believe the completion of enrollment in this Phase 3 trial positions FX006 ahead of competitive development programs in the U.S. targeting osteoarthritis of the knee, and assuming positive data from both pivotal trials, we will submit an NDA in the second half of 2016 to the FDA for regulatory approval."
Harry E. Rubash, M.D., Chief of the Department of Orthopaedic Surgery at Massachusetts General Hospital commented, "I believe the rapid enrollment in this trial is indicative of the unmet medical need in osteoarthritis therapy. Intra-articular corticosteroids are effective in temporary relief of osteoarthritis symptoms and enhancement of their effect with sustained residence in the joint could constitute a therapeutic advance."
About the Phase 3 Trial of FX006 in OA of the Knee
The randomized, double-blind Phase 3 trial is being conducted at over 40 centers worldwide. The 486 enrolled patients have been randomized to one of three treatment groups (1:1:1) and treated with a single IA injection of normal saline (placebo), 40 mg of FX006 or 40 mg of TCA (the current standard of care). Each patient is being evaluated for efficacy and safety at seven outpatient visits over 24 weeks after receiving an injection. The primary objective of this study is to assess the magnitude and duration of pain relief of FX006 at 12 weeks against placebo. The secondary objectives of this study are to assess the effect of FX006 on the magnitude and duration of pain relief relative to immediate-release TCA and the effect of FX006 on function, responder status, global impressions of change, stiffness and consumption of analgesic medications relative to both controls.
About FX006
FX006 is a potential 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, approximately 600 patients have been treated with FX006 in clinical trials. 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.
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 (including FX006), future clinical and regulatory timelines, and potential benefits of FX006 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, the fact that past clinical trial results may not be predictive of results in future trials, 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 fact that Flexion will require additional capital, including prior to commercializing FX006 or any of its 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 Flexion undertakes no obligation to update or revise any of the statements.
CONTACT: Media Contact
Jamie Lacey-Moreira
PressComm PR, LLC
T: 410-299-3310
jamielacey@presscommpr.com
Corporate Contact
Lisa Davidson, MBA
Vice President, Finance and Administration
Flexion Therapeutics, Inc.
T: 781-305-7765
ldavidson@flexiontherapeutics.com
