Flexion Therapeutics Announces Presentation of Preliminary FX201 Clinical Data at the Upcoming 2021 American Society of Gene ...
April 28 2021 - 7:30AM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) will present preliminary
data from a Phase 1 single ascending dose (SAD) trial of FX201 at
the 2021 American Society of Gene & Cell Therapy (ASGCT) annual
meeting taking place virtually May 11-14, 2021.
“We are pleased to share preliminary clinical data from our
FX201 single ascending dose trial at the American Society of Gene
& Cell Therapy annual meeting,” said Michael Clayman, M.D.,
President and Chief Executive Officer of Flexion. “While the Phase
1 SAD study is principally designed to evaluate the safety and
tolerability of FX201, it is encouraging to see an early signal of
clinical activity in the low-dose cohort with two of the five
patients treated reporting substantial pain relief that lasted
through at least Week 24. We look forward to providing updated data
from this cohort at ASGCT on May 11.”
The clinical data will be presented in a digital presentation
entitled, Interim Data from the First-in-Human Phase 1 Trial of
FX201, An Intra-Articular, Helper-Dependent Adenoviral Gene Therapy
for Osteoarthritis - Safety, Tolerability, Biodistribution, and
Preliminary Evaluation of Clinical Activity in 5 Patients (Abstract
594). Key findings included in the ASCGT abstract:
- FX201 was generally well-tolerated in the initial low-dose
cohort.
- Two patients had self-limited Grade 2 index-knee AEs (pain,
swelling, effusion) possibly related to treatment, managed
conservatively.
- No evidence of systemic biodistribution of FX201 in plasma or
shedding in urine or at the injection site was observed in any
patient, indicating that the vector remained in the encapsulated
joint space.
- Based on IMMPACT1 criteria, two out of the five patients (40%)
demonstrated substantial improvement in knee OA pain at Weeks 8,
12, and 24 following treatment with FX201.
Flexion will present longer term follow-up data from the
low-dose cohort in a video presentation available on the ASGCT
website at the start of the conference on May 11.
About FX201FX201 is an investigational gene
therapy which utilizes a helper-dependent adenovirus (HDAd) vector
devoid of all viral genes that carries a coding sequence for an
anti-inflammatory protein called interleukin-1 receptor antagonist
(IL-1Ra) under the control of an inflammation-responsive promoter.
FX201 is injected directly into the joint space (also termed the
intra-articular space) and is intended to deliver as-needed
anti-inflammatory activity to joint tissues, with the goal of
providing at least 6 to 12 months of meaningful pain relief and
functional improvement following a single injection with the
possibility of slowing disease progression.
About Flexion TherapeuticsFlexion 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 OA, the most common form of arthritis. The company's core
values are focus, ingenuity, tenacity, transparency, and fun.
Please visit flexiontherapeutics.com.
Forward-Looking StatementsThis press 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;
timing and plans with respect to the Phase 1 clinical trial of
FX201; and the potential therapeutic and other benefits of FX201,
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 the impacts and expected duration of the COVID-19 pandemic are
uncertain and rapidly changing; the risk that we may not be able to
maintain and enforce our intellectual property, including
intellectual property related to FX201; risks related to clinical
trials, including potential delays, safety issues, or negative
results; the fact that future results may not be consistent with
preliminary results or results from prior studies or trials; and
other risks and uncertainties described in our filings with the
Securities and Exchange Commission (SEC), including under the
heading “Risk Factors” in our Annual Report on Form 10-K for the
year ended December 31, 2020, filed with the SEC on
March 10, 2021, 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.
Contacts:
Scott YoungVice President, Corporate Communications &
Investor RelationsFlexion Therapeutics, Inc.T:
781-305-7194syoung@flexiontherapeutics.com
Julie DownsAssociate Director, Corporate Communications &
Investor Relations Flexion Therapeutics, Inc.T:
781-305-7137jdowns@flexiontherapeutics.com
- The Initiative on
Methods, Measurement, and Pain Assessment in Clinical Trials
(IMMPACT) recommended that six core outcome domains should be
considered when designing chronic pain clinical trials. These six
core outcome domains were: (1) pain; (2) physical functioning; (3)
emotional functioning; (4) participant ratings of improvement and
satisfaction with treatment; (5) symptoms and adverse events; and
(6) participant disposition.
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