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Flexion Therapeutics Enrolls First Patient in Phase 2 Trial of Zilretta™ Among Type 2 Diabetes Patients With Knee Osteoarthritis

BURLINGTON, Mass., April 28, 2016 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today reported it has enrolled the first patient in a clinical trial to assess the effects of its lead drug candidate, Zilretta (also known as FX006), on blood glucose levels in approximately 36 adults with osteoarthritis (OA) of the knee who also have Type 2 (adult) diabetes.

“This clinical trial in patients with OA of the knee will assess whether Zilretta, an investigational intra-articular (IA) sustained-release steroid (triamcinolone acetonide or TCA) treatment, can avoid the substantial elevations in blood glucose levels that often occur in diabetic patients treated with immediate-release TCA,” said Michael Clayman, M.D., Flexion Therapeutics President and Chief Executive Officer. “Following an IA injection of immediate-release TCA, plasma concentrations of TCA rise rapidly to levels that may cause hyperglycemia in this patient population. Because peak plasma concentrations after a Zilretta injection, as demonstrated in clinical trials, are more than an order of magnitude lower than with immediate-release TCA, we believe it’s reasonable to expect that injections of Zilretta may avoid these increases in blood sugar. If the data support this expectation, Zilretta could confer an important safety advantage for the 750,000 people in the U.S. with knee OA who have diabetes and receive IA corticosteroid injections annually.”

In this randomized, double-blind parallel comparison, researchers at up to eight U.S. sites will use continuous glucose monitoring to compare the effects on blood sugar levels of a single IA administration of 40 mg of Zilretta with the effects of an injection of 40 mg of immediate-release TCA. The objective of the study is to examine if Zilretta has effects on blood glucose levels that differ from immediate-release TCA.

Zilretta was designed using proprietary microsphere technology and is intended to provide localized and long-lasting pain relief over a period of months while minimizing systemic exposure and avoiding serious side effects common to oral therapies prescribed for OA pain. Current oral treatment options for OA knee pain include non-steroidal anti-inflammatory drugs (NSAIDS), COX II inhibitors and opioids. All are labeled with black box warnings for serious, sometimes fatal, side effects. IA medicines, such as immediate-release corticosteroids and hyaluronic acid injected into the joint, are generally well tolerated but fail to produce pain relief of sufficient magnitude or duration.

Due to the large unmet need among knee OA patients, the U.S. Food & Drug Administration (FDA) has granted Zilretta Fast Track designation. Flexion recently announced positive results from its Phase 3 clinical trial for Zilretta and has scheduled a pre-New Drug Application (NDA) meeting in May with the FDA with the intent to gain the Agency’s endorsement to submit an NDA in the second half of 2016.

About Osteoarthritis of the Knee

OA is a common joint disease that affects 27 million Americans, and the prevalence of the disease is expected to significantly grow as a result of aging, obesity and sports injuries. OA is a type of degenerative arthritis that is caused by the progressive breakdown and eventual loss of cartilage in one or more joints. OA is characterized by pain, swelling, stiffness and decreased mobility of the affected joint. While OA is being diagnosed at increasingly younger ages, prevalence rises after age 45, and the knee is one of the most commonly affected joints. In 2014, more than 12 million Americans were diagnosed with OA of the knee. OA has a significant impact on the daily lives of patients, and it commonly affects large weight-bearing joints like the knees and hip but also occurs in the shoulders, hands, feet and spine. As the disease progresses, it becomes increasingly painful and debilitating, culminating, in many cases, in the need for total joint replacement.

Each year, at least five million OA patients in the U.S. receive immediate-release corticosteroid and hyaluronic acid IA injections for knee pain, but these injections generally provide limited relief, and no alternative injectable therapy has been approved in more than a decade. Opioids are another treatment option, and as many as 40 percent of Medicare patients are prescribed opioids for chronic OA pain.

About Zilretta

Zilretta is being investigated as the first IA sustained-release, non-opioid treatment for patients with moderate to severe OA pain. Zilretta employs proprietary microsphere technology combining TCA — a commonly administered, short-acting corticosteroid — with a polymer (PLGA) intended to provide persistent therapeutic concentrations of drug locally to both amplify the magnitude and prolong the duration of pain relief.

To date, over 600 patients have been treated with Zilretta in clinical trials. No drug-related serious adverse events have been observed in these trials and adverse events have typically been localized, mild and comparable to those observed with immediate-release TCA and placebo. The efficacy data from these trials are consistent with Zilretta providing meaningful and durable pain relief.

About Flexion Therapeutics

Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company's lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive IA injections for knee OA annually. The company is also investigating another product candidate, FX007, a locally administered TrkA receptor antagonist for post-operative pain.

Forward-Looking Statements

Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; our ongoing development of Zilretta and our other product candidates; our interpretation of the data and results from our Zilretta clinical trials; our plans for, and the expected timing of, our Zilretta NDA submission with the FDA; our plans to commercialize Zilretta and its market potential; and the potential therapeutic and other benefits of Zilretta and our other product candidates, 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, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; the fact that results of past clinical trials may not be predictive of subsequent trials; our reliance on third parties to manufacture and conduct clinical trials of Zilretta and our other product candidates, which could delay or limit their future development or regulatory approval; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for Zilretta; the fact that we will require additional capital, including prior to commercializing Zilretta or any of our other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to us; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta and our other product candidates; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta or our other product candidates; the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. 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. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Investor Contact David Carey Lazar Partners LTD T: 212-867-1768 dcarey@lazarpartners.com Media Contact Mariann Caprino TogoRun T: 917.242.1087 M.Caprino@togorun.com Corporate Contact Fred Driscoll Chief Financial Officer Flexion Therapeutics, Inc. T: 781-305-7763 fdriscoll@flexiontherapeutics.com

Source:Flexion Therapeutics