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Flexion Therapeutics Announces New In Vitro Data Showing Protective Effects of Triamcinolone Acetonide on Cartilage

  • Study conducted in collaboration with MIT showed that triamcinolone acetonide had protective effects on inflamed and/or injured cartilage in an established preclinical model
  • Data presented in “late breaker” session at the recent 2019 Orthopaedic Research Society Annual Meeting

/EIN News/ -- BURLINGTON, Mass., Feb. 21, 2019 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced results from a preclinical study which showed that triamcinolone acetonide (TA) had protective effects on inflamed and/or injured cartilage. Led by Professor Alan Grodzinsky, Sc.D., Director of the Center for Biomedical Engineering at the Massachusetts Institute of Technology (MIT), the study utilized an established in vitro model1 with cartilage explants subjected to inflammatory cytokines and a single impact mechanical injury. This in vitro model was used to assess the effects of a range of doses of TA on cartilage tissue explants during a 1-week treatment regimen.

The new data were unveiled in a “late breaker” poster presentation, “Dose-Dependent Chondroprotective Effects of Triamcinolone Acetonide on Inflamed and Injured Cartilage Using an In Vitro Model” (#2202), at the recently held Orthopaedic Research Society (ORS) annual meeting where Professor Grodzinsky was presented with the ORS/Orthopaedic Research and Education Foundation Distinguished Investigator Award for 2019.

“In light of prior conflicting data about the impact of corticosteroids on cartilage structure, these data are particularly compelling because they suggest that, at the low doses used in this 1-week in vitro study, TA does not induce cartilage matrix degradation in ‘normal’ cartilage,” said Professor Grodzinsky. “Furthermore, these data indicate that TA can dose dependently protect against, and even restore, the decrease in matrix biosynthesis caused by inflammatory mediators in the synovial fluid combined with injurious compression of cartilage.”

Michael Clayman, M.D., President and Chief Executive Officer of Flexion Therapeutics added, “These new data are consistent with our previously published in vivo data which show that TA, at persistent therapeutic concentrations in diseased joints, provides structural benefit.”2

Key Findings from the Study Relative to OA:

  • In an in vitro model, the administration of pro-inflammatory cytokines and/or mechanical injury to cartilage explants resulted in a reduction of cartilage matrix biosynthesis and an increase in cartilage matrix breakdown.
  • The administration of TA in inflamed and/or injured cartilage tissue had protective effects, such as restoration of cartilage matrix biosynthesis and prevention of cartilage matrix breakdown, and no detrimental effects were observed at any dose in inflamed or injured cartilage.

The study was funded by Flexion Therapeutics through a research grant to MIT. Professor Grodzinsky received no compensation from Flexion for his work.  

About Osteoarthritis (OA) of the Knee
OA, also known as degenerative joint disease, affects more than 30 million Americans 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 two years, Flexion has been named one of the Best Places to Work by the Boston Business Journal and a Top Place to Work in Massachusetts by The Boston Globe.

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, the potential impact of triamcinolone acetonide on inflamed and/or injured cartilage, and expected increases in the prevalence of OA, 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, the fact that preclinical study results may not be predictive of results in clinical trials or from commercial use of a product; 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 or product supply 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 September 30, 2018 filed with the SEC on November 7, 2018 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.

References

  1. Lu YCS, Evans CH, Grodzinsky AJ.  Effects of short-term glucocorticoid treatment on changes in cartilage matrix degeneration and chondrocyte gene expression induced by mechanical injury and inflammatory cytokines.  Arthritis Res Ther. 2011; 13(5): R142
  2. Kumar A et al. Sustained efficacy of a single intra-articular dose of FX006 in a rat model of repeated localized knee arthritis. Osteoarthritis Cartilage. 2015;23(1):151-160

Contacts:

Scott Young
Vice President, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7194
syoung@flexiontherapeutics.com

Julie Downs
Manager, Corporate Communications
Flexion Therapeutics, Inc.
T: 781-305-7137
jdowns@flexiontherapeutics.com

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Distribution channels: Healthcare & Pharmaceuticals Industry


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