Flexion Therapeutics Announces Positive Preclinical Data Supporting Development of FX301, a Locally Administered Nav1.7 Inhib...
April 27 2020 - 7:30AM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced new
positive preclinical efficacy and pharmacokinetic (PK) data for
FX301, its locally administered peripheral nerve block candidate
for control of post-operative pain. Results demonstrated sustained
analgesic effect in a preclinical surgical pain model for the
duration of the study (72 hours) following a single injection of
FX301, and no impairment of motor function. The data were presented
in an electronic poster presentation available on the American
Society of Regional Anesthesia and Acute Pain Medicine’s (ASRA)
website.
“These compelling data bolster our excitement about the
potential for FX301 to solve the issues that have plagued most pain
drug candidates in the NaV1.7 inhibitor class and address a key
unmet need in post-operative pain management – to provide durable
and meaningful post-operative pain relief while sparing motor
function,” said Michael Clayman, M.D., President and Chief
Executive Officer of Flexion. “In contrast to liposomal
bupivacaine, FX301, through its innovative mechanism of action,
provided improved analgesic effect while preserving motor function.
These results support the potential for FX301 to become a
differentiated peripheral nerve block product which could enable
more rapid post-operative ambulation and rehabilitation than
existing nerve blocks. We look forward to advancing the FX301 GLP
toxicology studies this year and intend to initiate human trials in
2021.”
The study evaluated the efficacy and PK profile of FX301
following ultrasound-guided sciatic nerve block in a validated
post-operative pain model in pigs. The pigs were divided into three
study groups (n=6 per group), anesthetized and given a single 10 ml
injection of either FX301 (13 mg/mL; total dose 130 mg), liposomal
bupivacaine (13.3 mg/mL; total dose 133 mg) or placebo (normal
saline) in close proximity to the sciatic nerve prior to receiving
a surgical incision on the hind limb. Pain was assessed at 1, 4, 8,
12, 24, 36, 48, and 72 hours post-injection. Motor function was
evaluated at 2 and 24 hours post-injection.
Key findings from the study include:
- FX301 provided both greater analgesic effect from 12 through 72
hours and a longer duration of effect through 72 hours compared to
liposomal bupivacaine or placebo;
- Treatment with FX301 did not significantly affect total walking
distance in animals at 2 and 24 hours post-injection; animals
treated with liposomal bupivacaine experienced a significant
reduction in total walking distance compared with baseline at 2 and
24 hours post-injection; and
- Systemic plasma profile of funapide, the active ingredient in
FX301, remained relatively flat throughout the study, indicative of
controlled drug release from the thermosensitive gel formulation,
while high local concentrations of funapide were observed at the
site of administration at 72 hours.
An encore presentation of these findings was accepted at the
International Anesthesia Research Society (IARS) annual
meeting.
About FX301 FX301 is a locally administered
NaV1.7 inhibitor product candidate, known as funapide, formulated
for extended release in a thermosensitive hydrogel. The initial
development of FX301 is intended to support administration as a
peripheral nerve block for control of post-operative pain. Flexion
believes FX301 has the potential to provide effective pain relief
while preserving motor function and anticipates initiating clinical
trials in 2021.
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 people with musculoskeletal
conditions, beginning with osteoarthritis, the most common form of
arthritis. The Company's core values are focus, ingenuity,
tenacity, transparency and fun.
Visit flexiontherapeutics.com.
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;
expected clinical developments and clinical trial timelines; and
the potential therapeutic and other benefits of FX301, 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
related to clinical trials, including potential delays, safety
issues or negative results; risks related to key employees,
markets, economic conditions, and health care reform; 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 filed with the SEC on March 12,
2020 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 Young Vice President, Corporate Communications &
Investor Relations Flexion Therapeutics, Inc. T: 781-305-7194
syoung@flexiontherapeutics.com
Julie Downs Associate Director, Corporate Communications &
Investor Relations Flexion Therapeutics, Inc. T: 781-305-7137
jdowns@flexiontherapeutics.com
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