BURLINGTON, Mass., Sept. 9, 2014 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Patent and Trademark Office has issued a composition of matter patent (No. 8828440), entitled "Corticosteroids for the Treatment of Joint Pain," which provides coverage for FX006, the company's lead clinical product candidate. FX006 is a novel, non-opioid, sustained-release, intra-articular (IA) formulation of triamcinolone acetonide (TCA). The patent describes and claims an injectable formulation comprised of controlled or sustained-release microparticles that contain TCA in a poly(lactic-co-glycolic) acid co-polymer (PLGA) matrix.
"The issuance of this patent marks an important milestone for Flexion as it directly protects our lead product, FX006, for a prolonged period of time and provides a critical foundation for its eventual commercialization," said Michael Clayman, M.D., President and CEO. "Based on the available clinical data to date, we are enthusiastic about the prospect of FX006 playing an important role in the treatment of patients with osteoarthritis (OA) of the knee. This patent, together with last week's announcement on the planned start of our pivotal Phase 3 clinical trial for FX006 a year ahead of schedule, brings us closer to realizing the potential of this novel therapy."
FX006 is designed to provide prolonged pain relief for the treatment of OA of the knee, while potentially avoiding untoward systemic effects associated with immediate-release steroids. Last year Flexion announced the results of a Phase 2b OA dose-ranging trial that demonstrated that FX006 provided superior pain relief compared to the standard of care IA immediate-release steroid. Flexion also recently announced positive topline clinical trial results from a Phase 2a synovial fluid pharmacokinetic (PK) trial of FX006, which demonstrated, for the first time, that a single IA injection of FX006 can provide therapeutic concentrations of FX006 in joint fluid for at least 12 weeks. A pivotal Phase 2b confirmatory clinical trial for FX006 is currently enrolling patients and topline data are expected in the first half of 2015. Based on a recent meeting with the U.S. Food and Drug Administration (FDA) to review the clinical development program for FX006, Flexion earlier this month announced plans to accelerate the initiation of a pivotal Phase 3 clinical trial for FX006 to late 2014 and expects to complete the trial by the second half of 2015. The Phase 3 trial will be an international, multi-center, randomized, blinded, single-dose study in 462 patients with OA of the knee. It will have three separate arms that include a 40 mg dose of FX006, placebo, and a 40 mg dose of TCA. The primary objective of the trial will be to provide the second pivotal efficacy dataset against placebo for an NDA submission. In addition, the trial will provide a key comparative dataset against the current standard of care, immediate-release TCA, and could potentially support a commercial advantage in the launch of the drug.
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 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, the potential duration and impact of patent protection for FX006, anticipated clinical and other milestones (including the timing of such milestones), and potential role of FX006 in the treatment of patients with OA of the knee 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 completing Phase 3 development of, filing for regulatory approval for, or 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, 2013 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.