Flexion Therapeutics to Present Data on Zilretta™ (FX006) at the American Diabetes Association’s 77th Scientific Sessions...
June 10 2017 - 1:00PM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) will present the full
results from a Phase 2 study which found its lead investigational
product candidate Zilretta (also known as FX006) was associated
with reduced blood glucose (BG) elevation compared with immediate
release triamcinolone acetonide in crystalline suspension (TAcs) in
patients with Type 2 diabetes and knee osteoarthritis (OA). Flexion
reported the top-line results from this study in November 2016, and
the full analysis will be presented in a poster session (abstract
#1091-P) on June 11 at 12:00 p.m. PDT during the American Diabetes
Association’s 77th Scientific Sessions.
Approximately 20 percent of patients with osteoarthritis of the
knee also have Type 2 diabetes.1 While intra-articular (IA)
injections of corticosteroids are commonly used to manage pain and
inflammation associated with knee OA, the rapid systemic absorption
of these medications results in elevated BG levels. Changes in BG
concentrations can pose important clinical challenges in diabetic
patients.2
The objective of the double-blind, randomized, parallel-group
study was to examine BG concentrations following a single injection
of 40 mg Zilretta or 40 mg TAcs. Thirty-three patients with Type 2
diabetes and knee OA who were actively being treated with one or
two oral diabetes medications were enrolled in the study and
randomized 1:1. Blood glucose levels were monitored continuously
for one week prior and for two weeks following injection. The
primary endpoint was change in average BG concentration from the 3
day pre-treatment baseline period to the 3 day post-treatment
period for Zilretta versus TAcs.
The primary endpoint of the study was met, with patients
experiencing a significantly lower change in average BG
concentration following administration of Zilretta (14.7 mg/dL)
compared with TAcs (33.9 mg/dL). In addition:
- Mean average BG levels increased significantly from the
pre-treatment baseline period to the post-treatment period in
patients receiving TAcs but did not change significantly in
patients receiving Zilretta,
- The percent of time that average BG levels were within the
American Diabetes Association’s target range was greater for
Zilretta compared with TAcs, a clinically important indication of
improved glycemic control,
- During the post-treatment period, significantly less glycemic
variability was observed following IA injection of Zilretta
compared with TAcs.
The poster authors attribute these results to the low systemic
exposure to triamcinolone acetonide from the extended-release
formulation of Zilretta compared with immediate release TAcs.
Incidences of adverse events (AEs) in the study were low and
similar between the Zilretta and TAcs treatment arms. All AEs were
Grade 1 (Zilretta: 0/18, 0%; TAcs: 2/15, 13.3%) or Grade 2
(Zilretta: 2/18, 11.1%; TAcs: 0/15, 0%). No patients treated with
Zilretta experienced an index-knee or injection-related AE.
“Treating OA-related knee pain in patients with Type 2 diabetes
can be complicated by the hyperglycemia which commonly occurs
following the use of immediate-release corticosteroids. The
findings from this study suggest that Zilretta may significantly
reduce those blood glucose spikes by delivering a slower and
extended release of corticosteroid in the knee joint and minimizing
systemic exposure,” said Michael Clayman, MD, President and CEO of
Flexion. “We believe that Zilretta, if approved, has the potential
to provide extended pain relief while supporting these patients in
their efforts to maintain consistent blood glucose levels.”
About Osteoarthritis of the Knee While OA is
being diagnosed at increasingly younger ages, prevalence rises
after age 45. In 2015, more than 14 million Americans were
diagnosed with OA of the knee. OA represents an enormous burden on
the U.S. healthcare system, affecting approximately 31 million
individuals and accounting for more than $185 billion in annual
expenditures. About 13 percent of women and 10 percent of men aged
60 years and older have symptomatic OA of the knee, with rates
likely to increase due to the aging of the population and the rate
of obesity or overweight individuals in the general population.
Each year, more than five million OA patients in the United
States receive either an immediate-release corticosteroid or
hyaluronic acid intra-articular injection for knee pain.
About Zilretta Zilretta is being investigated
as the first intra-articular, extended-release treatment for
patients with OA 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. In February 2017, the U.S.
Food and Drug Administration (FDA) accepted Flexion's New Drug
Application (NDA) for Zilretta in OA of the knee. Under the
Prescription Drug User Fee Act (PDUFA), the agency has established
a user fee goal date of October 6, 2017.
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 analgesia for the millions of
U.S. patients who receive intra-articular injections for OA related
knee pain annually.
Forward-Looking StatementsStatements 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 benefits of Zilretta; and expected increases
in the incidence of 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, manufacturing and obtaining regulatory
approval for drugs that are safe and effective for use as human
therapeutics; competition from alternative therapies; regulatory
developments and safety issues, including difficulties or delays in
obtaining regulatory approvals to market Zilretta; the risk that
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.
1 IMS PharMetrics Plus Database. 2014 – 2015.2 Habib
GS. Clin Rheumatol 2009;28:749–56.
Corporate Contact:
Scott Young
Sr. Director, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7194
syoung@flexiontherapeutics.com
Media Contact:
Danielle Lewis
Lazar Partners
T: 212-867-1768
flexionpr@lazarpartners.com
Investor Contact:
David Carey
Lazar Partners
T: 212-867-1768
dcarey@lazarpartners.com
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