Centrexion Therapeutics Corporation, a company focused on
developing non-opioid, non-addictive therapeutics for the treatment
of chronic pain, today announced that it will present new data from
clinical trials of CNTX-4975, including an assessment of
refinements of the company’s proprietary method for CNTX-4975
administration, at the 2019 Florida Society for Interventional Pain
Physicians Conference (FSIPP), taking place July 18-21, 2019 in
Hollywood, Florida.
“This open-label trial in patients with bilateral,
painful knee osteoarthritis (OA), tested shorter durations of
cooling and different types of cooling methods, including readily
available devices such as ice-gel packs, as well as using one- or
two- intra-articular (IA) injection techniques for lidocaine and
1.0 mg of CNTX-4975,” said Randall M. Stevens, M.D., chief medical
officer of Centrexion. “We are pleased with the newest results,
which are consistent with other clinical trials, which showed that
the refinements to our proprietary technique for IA) injection of
CNTX-4975 for painful knee OA were able to reduce post-procedure
discomfort.”
In this presentation of the clinical trial, 10
patients with bilateral painful knee OA received an IA injection of
CNTX-4975 in the first knee, followed by a treatment of the second
knee seven days later.
- Mean pain with walking scores decreased from 5.9 at baseline to
1.6, using the Numeric Pain Rating Scale (NPRS; 0-10) at day 42,
for a 73% pain reduction (P<0.001, two-tailed, paired t
test).
- Five to six weeks post-procedure, seven patients reported a
pain level ≤2, and three patients reported no pain in either
knee.
- All patients reported improvement in both knees using the
Patient Global Impression of Change.
These results are consistent with the pain reductions reported
in the Phase 2 double-blind, randomized, controlled trial
evaluating a single injection of CNTX-4975 1.0 mg in patients with
moderate-to-severe OA knee pain (TRIUMPH)1.
Ongoing Assessment of Methods to Optimize the CNTX-4975
Administration ProcedureTwo cooling devices are being
assessed in the ongoing Phase 3 VICTORY-3 open label, 8-week
clinical trial to manage post-procedure comfort: an ice-water
cooling pump with a knee wrap and an ice-gel pack knee wrap. This
study also investigates shorter cooling times and the use of one-
or two-injection techniques for lidocaine and 1.0 mg of CNTX-4975.
In total, five variants of the administration procedure are
incorporated into the trial.
- An interim analysis based on data from 719 patients (1,087
knees treated) of the planned 850, suggests overall post-procedure
discomfort across the groups has been well managed and similar to
that observed with the 1.0 mg CNTX-4975 group in the TRIUMPH
trial.
- The average overall post-procedure discomfort 30-minutes after
treatment was similar to or less than the average overall baseline
knee pain at rest before the procedure and ranged from 1.4 to 2.0
(0-4 scale), depending on the group.
- IA injection technique using a single needle with lidocaine and
CNTX-4975 injections separated by three minutes was as well
tolerated as lidocaine and CNTX-4975 given with two separate
injections, separated by 30 minutes of cooling.
“In this ongoing Phase 3 VICTORY-3 trial, we have interim data
that show reductions in pain with walking similar to those observed
in the Phase 2 trial. In particular, as with prior trials, patients
with moderately severe to severe pain on average experienced a
reduction to mild pain. More than 80% of patients with bilateral
painful knee OA received the second treatment into the other
painful OA knee one week later. In addition, of the bilateral
subjects that did not have the other knee treated, the majority
indicated that they were mostly or completely satisfied with the
first procedure,” continued Dr. Stevens. “We intend to continue to
evaluate variations of the CNTX-4975 administration procedure
designed to optimize the physician and patient experience and
convenience.”
Details of the abstracts and poster presentations are listed
below.
Title: Efficacy of
Bilateral Intra-articular CNTX-4975 Injection for Management of
Painful Knee Osteoarthritis Presentation Time:
Friday, July 19: 10:15am – 10:45am, 3:30pm – 4:00pm Saturday, July
20: 10:00am – 10:30am, 3:00pm – 3:30pmLocation:
Diplomat 1-3Online publication:
https://www.fsipp-conference.com/pdf/FSIPP 2019 Educational
Guide.pdf
Title: Assessment of
Cooling Methods for Reducing Procedural Pain Associated With
CNTX-4975 Injection for the Management of Painful Knee
Osteoarthritis Presentation Time: Friday, July 19:
10:15am – 10:45am, 3:30pm – 4:00pmSaturday, July 20: 10:00am –
10:30am, 3:00pm – 3:30pmLocation: Diplomat
1-3Online publication:
https://www.fsipp-conference.com/pdf/FSIPP 2019 Educational
Guide.pdf
About the Phase 3 VICTORY Program
The Phase 3 VICTORY clinical program consists of three studies.
VICTORY-1 and VICTORY-2 are pivotal, randomized, double-blind,
placebo-controlled, 52-week clinical trials to evaluate the
efficacy and safety of intra-articular (IA) injections of CNTX-4975
in people with chronic, moderate-to-severe pain resulting from knee
osteoarthritis (OA). VICTORY-1 is a 332-patient, single dose study
to evaluate a single injection of CNTX-4975. VICTORY-2 is a
332-patient study evaluating a repeat dose, administered 6 months
after the first dose. The primary endpoint of both studies is the
change in pain with walking, measured at Week 12, using the Numeric
Pain Rating Scale (NPRS; 0-10). Secondary endpoints at Week 12
include improvement in the average knee stiffness and function
(Western Ontario and McMaster Universities Osteoarthritis Index
[WOMAC B, stiffness and WOMAC C, functional scale]). Additional
secondary endpoints will be measured out to week 52, including
change in knee pain (WOMAC A), knee stiffness and function (WOMAC B
and C, respectively), Patient Global Impression of Change (PGIC),
the Knee Injury and Osteoarthritis Scale, and additional patient
reported outcome measures. The VICTORY-3 trial is an open label,
8-week trial to evaluate the safety of a single IA injection of 1.0
mg of CNTX-4975 into one or two knees in 850 patients with chronic
moderate-to-severe pain resulting from knee OA. In addition to
expanding the safety database for CNTX-4975, VICTORY-3 is also
evaluating variations of the procedure pain control technique
designed to enable physicians to select options that could best fit
their practice dynamics and patient needs if CNTX-4975 is
approved.
About Osteoarthritis
Osteoarthritis (OA) is the most common joint disease in the
U.S., currently affecting more than 30 million Americans, according
to the U.S. Centers for Disease Control, with similar prevalence in
Europe. OA occurs when cartilage, the tissue that envelops the
structural bones within a joint, gradually deteriorates. These
changes cause pain, swelling and problems moving the joint.
Although OA can affect any joint, it most often affects joints in
the knees, hips, lower back and neck and small joints of the
fingers and the bases of the thumb and big toe. Over time, patients
with knee OA tend to become inactive due to pain and joint
stiffness and reduced function.
About CNTX-4975
CNTX-4975, Centrexion’s most advanced product candidate, is an
investigational synthetic, ultra-pure intra-articular injection of
trans-capsaicin for the treatment of moderate to severe pain
associated with knee osteoarthritis (OA). CNTX-4975 is designed to
be administered directly into the joint where the pain stimulus
originates and to selectively and locally target and disrupt the
signaling of pain-sensing nerve fibers. In January 2018, CNTX-4975
was granted Fast Track Designation by the U.S. Food and Drug
Administration for the treatment of pain associated with knee
OA.
About Centrexion Therapeutics
Centrexion is a late clinical-stage biopharmaceutical company
focused on becoming the leader in identifying, developing and
commercializing novel, non-opioid and non-addictive therapies to
address the large unmet medical need for the treatment of chronic
pain.
1 Stevens, RM Controlled Clinical Trial of Intra-Articular
CNTX-4975 (trans-capsaicin) for Pain Associated with Osteoarthritis
of the Knee, Arthritis Rheumatol. 2019 Mar 19.
https://onlinelibrary.wiley.com/doi/epdf/10.1002/art.40894
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