Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced results
from two new analyses of the company’s lead investigational drug
candidate, Zilretta (also known as FX006), for the treatment of
osteoarthritis (OA) related knee pain. The clinical findings will
be presented at the Osteoarthritis Research Society International
(OARSI) 2017 World Congress, taking place April 27-30 in Las Vegas.
Clinical Data Presentations:
Title: An Intra-articular, Extended
Release Formulation of Triamcinolone (FX006) Affords Clinically
Relevant Improvements in Pain and Function of Knee Osteoarthritis:
Post-Hoc Pooled Analysis of 3 Randomized Controlled Trials
Poster: 715 Date and Time: Poster
Session 1: 4/28, 12:00 PM – 12:30 PM; Poster Session 2: 4/28, 4:00
PM – 4:30 PM; Poster Session 3: 4/29, 3:30 PM – 4:15 PMThe authors
examined improvements in pain and function using pooled data from
three Phase 2 and 3 randomized trials, which individually
demonstrated statistically significant reductions in weekly mean
scores of Average Daily Pain (ADP). Utilizing data from 798
patients, the researchers sought to more fully characterize the
clinical relevance of Zilretta using several established
assessments including:
- Outcome Measures in Rheumatology (OMERACT)-OARSI strict
responder definition (≥50% and absolute change of 20 in either
WOMAC-A-Pain or WOMAC-C-Function1),
- Proportions of patients reporting ≥30% (moderate) and ≥50%
(substantial) improvements in WOMAC-A-Pain,
- Standardized effect size calculations for ADP-intensity and
WOMAC-A-Pain scores.
Zilretta was associated with clinically significant improvements
in these WOMAC-based assessments of pain and function compared with
saline-placebo (through Week 12) and triamcinolone acetonide
crystalline suspension (TAcs) (through Weeks 8 and/or 12). The
poster also highlights an analysis demonstrating that Zilretta may
represent the first intra-articular treatment to achieve the
WOMAC-based minimum clinically important improvement (MCII)
criteria, established by the American Academy of Orthopaedic
Surgeons (AAOS). The MCII criteria reflect the smallest clinical
change that is important to patients, recognizing that there are
some treatment-related statistically significant improvements that
are too small to be relevant.2
Title: Synovial and Systemic Pharmacokinetics of
Triamcinolone Acetonide Following Intra-Articular Injection of an
Extended Release Formulation (FX006) or Standard Crystalline
Suspension in Patients with Knee
OsteoarthritisPoster: 712 Date
and Time: Poster Session 1: 4/28, 12:00 PM – 12:30 PM;
Poster Session 2: 4/28, 4:00 PM – 4:30 PM; Poster Session 3: 4/29,
3:30 PM – 4:15 PM
This Phase 2, open-label study assessed the synovial fluid and
systemic concentrations of triamcinolone acetonide (TA) following a
single intra-articular (IA) injection of Zilretta. Eighty-one
patients received a single IA injection of Zilretta or the standard
crystalline suspension of TA (TAcs). A single IA injection of
Zilretta resulted in a sustained presence in the joint and slow
elimination into the systemic circulation in patients with knee OA.
The authors concluded that microsphere-based delivery of TA via IA
administration prolongs residency of TA and diminishes both peak
plasma levels of and total systemic exposure to TA.
Commenting on the two presentations, Michael Clayman, M.D.,
President and Chief Executive Officer of Flexion said, “The data
presented at OARSI confirm our belief in Zilretta’s potential to
provide extended, clinically relevant pain relief and functional
improvement in patients with knee OA when evaluated across several
important measures. Furthermore, the findings demonstrate
Zilretta’s ability to persist locally in the joint with reduced
total systemic exposure. This may be particularly important for
patients with Type 2 diabetes, who are susceptible to elevations in
blood glucose levels following immediate-release steroid
injections.” Dr. Clayman added, “We believe that, if
approved, Zilretta holds tremendous potential for patients
suffering from OA, a progressive and debilitating condition.”
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. To date, more than 800
patients have been treated with Zilretta in clinical trials.
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 interpretation of the data and results from our
Zilretta clinical trials; the potential regulatory approval of
Zilretta and potential benefits of Zilretta in treating patients,
if approved; and predicted rates of incidence of knee 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, 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; regulatory
developments and safety issues, including difficulties or delays in
obtaining regulatory approvals to market Zilretta; the risk that
the FDA and foreign regulatory authorities may not agree with our
interpretation of the data from our clinical trials of Zilretta;
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 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.
2 American Academy of Orthopaedic Surgeons. Treatment of
Osteoarthritis of the Knee: Evidence‐Based Guideline 2nd Edition.
May 18, 2013. Available at
http://www.aaos.org/research/guidelines/TreatmentofOsteoarthritisoftheKneeGuideline.pdf.
Accessed April 24, 2017.
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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