Flexion Therapeutics Announces Treatment of First Patient in Second Cohort of FX201 Phase 1 Dose-Escalation Trial
September 08 2020 - 4:30PM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced the
treatment of the first patient in the second cohort of the Phase 1
dose-escalation trial evaluating the safety and tolerability of
FX201, an investigational, intra-articular, IL-1Ra gene therapy
product candidate being developed for the treatment of
osteoarthritis (OA).
"We are encouraged by the continued progress of the single
ascending dose study of FX201,” said Michael Clayman, MD,
President and Chief Executive Officer of Flexion
Therapeutics. “OA is a painful, progressive disease which has
no cure and although it remains early days, the data from the first
cohort of five patients supports the advancement of this important
program which we believe could establish a new standard for
durability of pain relief and potentially modify disease
progression."
The open-label, dose-escalation study is expected to enroll 15
to 24 patients, 30-80 years of age and test three doses (low, mid
and high dose) of FX201 in cohorts of five to eight patients. Each
patient will only receive one injection of FX201. Following the
completion of the first cohort in which five patients
(Kellgren-Lawrence Grade 2 or 3) were treated with the low dose of
FX201, safety data were collected and reviewed by an independent
DMC. After evaluating the first cohort safety data, the DMC
supported continuing the trial and initiating treatment in the next
dosing cohort which will include KL Grade 4 patients. The Company
anticipates data from the study will be available in 2021.
About FX201FX201 (humantakinogene hadenovec) is
a novel, intra-articular gene therapy product candidate which
utilizes a helper-dependent adenovirus (HDAd) vector based on human
serotype 5 (Ad5) that is designed to transfer a gene to cells in
the joint to produce an anti-inflammatory protein, interleukin-1
receptor antagonist (IL-1Ra), under the control of an
inflammation-sensitive promoter. Inflammation is a known cause of
pain, and chronic inflammation is thought to play a major role in
the progression of OA. By persistently suppressing inflammation,
Flexion believes FX201 holds the potential to provide long-term
pain relief and functional improvement, and to modify the
disease.
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.
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
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; 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 June 30, 2020 filed with the SEC on August 5,
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.
Contact:
Scott YoungVice President, Corporate Communications &
Investor RelationsT:
781-305-7194syoung@flexiontherapeutics.com
Julie DownsAssociate Director, Corporate Communications &
Investor RelationsT:
781-305-7137jdowns@flexiontherapeutics.com
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