Flexion Therapeutics (NASDAQ:FLXN)
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6 Months : From Jun 2019 to Dec 2019
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced impressive new data from a post-hoc subgroup analysis of the open-label Phase 3b repeat administration trial of ZILRETTA (triamcinolone acetonide extended-release injectable suspension) in patients with osteoarthritis (OA) knee pain. The new findings were presented at the American Orthopaedic Society Sports Medicine (AOSSM) conference in Boston.
An exploratory analysis evaluating the efficacy of initial and repeat administration of ZILRETTA in patients with symptomatic knee OA ranging in radiographic severity from Kellgren-Lawrence (KL) Grades 2 to 4 indicated that ZILRETTA consistently reduced OA knee pain for 12 weeks after each injection, regardless of KL Grade. Deryk Jones, M.D., Section Head of Sports Medicine and Cartilage Restoration at the Ochsner Sports Medicine Institute presented these data during a podium presentation entitled, “Expanding the Potential of Nonoperative Therapies in Advanced Knee Osteoarthritis: Treatment Response to Repeat Administration Triamcinolone Acetonide Extended-Release is Similar Across KL Grades 2-4” (Paper 93) on Sunday, July 14 at AOSSM.
“These findings add to the growing body of data for ZILRETTA and highlight the important role it can play in helping patients manage recurrent OA knee pain,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “It is particularly gratifying to see data indicating that ZILRETTA appeared to reliably reduce knee pain in patients with KL Grade 4, the most radiographically severe form of OA, representing a new patient group not previously studied in our clinical trials.”
The analysis looked at 179 patients with OA knee pain who received two injections of ZILRETTA, 56 (31.3%) of whom had KL Grade 2, 68 (38.0%) had KL Grade 3, and 55 (30.7%) had KL Grade 4. The key findings from the analysis include:
- Median times to second injection were 16.1 weeks for KL Grade 2, 16.9 weeks for KL Grade 3, and 17.1 weeks for KL Grade 4;
- >80% of patients were considered moderate responders (≥30% reduction in pain) and ≥65% of patients were considered substantial responders (≥50% reduction in pain) at Week 12 following each injection;
- ZILRETTA appeared to reliably reduce knee OA pain with similar improvements observed after each injection across all KL Grade subgroups;
- Mean baseline WOMAC-A1 (pain) score was 2.15 across all KL groups;
- At Week 12, mean WOMAC-A scores were 1.24 and 1.20 (KL Grade 2), 1.37 each (KL Grade 3), and 1.34 and 1.36 (KL Grade 4) for the initial and second injection, respectively;
- Prior to injection, >77% of KL Grade 4 patients reported moderate to severe pain, and following initial and repeat ZILRETTA injections 92.5% and 82.4% of these patients, respectively, reported no to mild pain at the earliest timepoint measured (Week 4);
- 63.0% and 60.0% of KL Grade 4 patients reported no to mild pain at Week 12 following initial and repeat ZILRETTA injections, respectively; and
- The incidence of treatment emergent adverse events (AEs) were similar across all KL Grades and the most commonly reported AEs were consistent with those reported in previous clinical studies of ZILRETTA. Importantly, there were no indications of chondrolysis, osteonecrosis, subchondral insufficiency fractures, or clinically significant subchondral bone changes in any subgroup.
An encore presentation of these data will be held on Thursday, July 18 at the Southern Orthopaedic Association annual meeting.
Indication and Select Important Safety Information for ZILRETTA
Indication: ZILRETTA is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. It is not intended for repeat administration.
Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.
Warnings and Precautions:
- Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration.
- Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use.
- Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs.
- Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and if confirmed, institute appropriate antimicrobial treatment.
Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions.
Please see ZilrettaLabel.com for full Prescribing Information.
About ZILRETTA On October 6, 2017, ZILRETTA was approved by the U.S. FDA as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide — a commonly administered, short-acting corticosteroid — with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase 3 trial on which the approval of ZILRETTA was based showed that ZILRETTA significantly reduced knee pain for 12 weeks, with some people experiencing pain relief through Week 16. Learn more at www.zilretta.com.
About Osteoarthritis (OA) of the Knee OA, also known as degenerative joint disease, affects more than 30 million adults living in the U.S. and accounts for more than $185 billion in annual expenditures. In 2016, more than 15 million Americans were diagnosed with OA of the knee and the average age of physician-diagnosed knee OA has fallen by 16 years, from 72 in the 1990s to 56 in the 2010s. The prevalence of OA is expected to continue to increase as a result of aging, obesity and sports injuries. Each year, more than 15 million Americans are treated for OA-related knee pain, and approximately five million OA patients receive either an immediate-release corticosteroid or hyaluronic acid intra-articular injection to manage their knee pain.
About Flexion Therapeutics Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, a type of degenerative arthritis. The company's core values are focus, ingenuity, tenacity, transparency and fun. For the past three years, Flexion has been named one of the Best Places to Work by the Boston Business Journal, and Flexion was also recognized as a Top Place to Work in Massachusetts by The Boston Globe in 2017 and 2018.
Forward-Looking Statements This release contains forward-looking statements that are based on the current expectations and beliefs of Flexion. Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; ZILRETTA's market potential and potential benefits; expected increases in the rate of individuals with OA of the knee; and the potential therapeutic and other benefits of ZILRETTA, 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 developing and obtaining regulatory approval for product candidates; the fact that results of past clinical trials may not be predictive of subsequent trials; risks associated with commercializing new pharmaceutical products in the United States; the risk that we may not be able to successfully maintain an effective sales force to commercialize ZILRETTA; competition from alternative therapies; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to ZILRETTA; the risk that ZILRETTA may not be successfully commercialized, including as a result of limitations in ZILRETTA's label and package insert information; risks regarding our ability to obtain adequate reimbursement from payers for ZILRETTA; risks related to the manufacture and distribution of ZILRETTA, including our reliance on sole sources of supply and distribution; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; the risk that we may use our capital resources in ways that we do not currently expect; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 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.
1. WOMAC (Western Ontario and McMaster Universities Arthritis Index) is a validated, widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness and physical functioning of the joints.
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