Centrexion Therapeutics Announces Completion of Patient Enrollment in VICTORY-3 Phase 3 Open-Label Clinical Trial of CNTX-497...
September 17 2019 - 8:00AM
Centrexion Therapeutics Corporation, a company focused on
developing non-opioid, non-addictive therapies for the treatment of
chronic pain, today announced completion of patient enrollment in
its third Phase 3 trial, VICTORY-3. VICTORY-3 is a randomized,
open-label, single injection (per knee), eight-week study of 857
participants designed to streamline and optimize CNTX-4975
administration procedure and patient comfort as well as to evaluate
the efficacy and safety of an injection of 1.0 mg of CNTX-4975 in
patients with chronic moderate-to-severe knee osteoarthritis (OA)
pain in one or both knees. Topline results from VICTORY-3 are
expected to be reported in the first quarter of 2020.
VICTORY-3 will evaluate the comfort and ease of use of five
different cooling treatment regimens: Breg cooling, gel pack
cooling, shortened gel pack cooling and single needle injection gel
pack cooling with two different strengths of lidocaine (2% and
1%).
CNTX-4975 is an investigational synthetic, ultra-pure
intra-articular injection of trans-capsaicin that is designed to be
injected directly into the site of pain. It harnesses the natural
analgesic power of trans-capsaicin to provide durable and targeted
pain relief, with onset of response by the second day after
injection. Through its targeted delivery and highly selective
method of action, CNTX-4975 is designed to manage pain without
disrupting other nerve functions. In January 2018, CNTX-4975
received Fast Track designation by the U.S. Food and Drug
Administration (FDA) for the treatment of moderate-to-severe pain
associated with knee OA.
“We are pleased to have completed patient enrollment in
VICTORY-3 as this is an important milestone in our Phase 3
registrational clinical development program for CNTX-4975,” said
Jeffrey B. Kindler, chief executive officer of Centrexion
Therapeutics. “We are encouraged by the consistency of the positive
results across the program and look forward to reporting on the
results of VICTORY-3 and the first pivotal trial VICTORY-1 in Q1 of
2020. In Q3 of next year, we expect to report the results of the
second pivotal trial VICTORY-2.”
“In VICTORY-3, we are continuing to evaluate variations of the
CNTX-4975 administration procedure designed to maximize the
physician and patient experience and convenience. We are very
pleased to have already reported interim data demonstrating pain
reductions similar to those observed in the Phase 2 trial,” said
Randall M. Stevens, M.D., chief medical officer of Centrexion. “In
VICTORY-3, more than 80% of patients with bilateral painful knee OA
returned for the second treatment in the other knee one week later,
which we believe is supportive of a new therapeutic option which
may provide well tolerated pain relief to patients with
moderate-to-severe osteoarthritis knee pain.”
About the Phase 3 VICTORY ProgramThe 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 repeat doses, administered six months
apart. The primary endpoint of both studies is the change in pain
with walking measured at Week 12, using the Numeric Pain Rating
Scale (NPRS). 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]) measured at Week 12. 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),
functional outcomes and quality of life measures.
VICTORY-3 trial is an open label, eight-week trial to evaluate
the tolerability of a single IA injection of 1.0 mg of CNTX-4975 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 OsteoarthritisOsteoarthritis (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. 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, 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-4975CNTX-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 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
moderate-to-severe pain associated with knee OA.
About Centrexion Therapeutics
CorporationCentrexion 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.
Media ContactJulie Normart, W2O pure+1 (559)
974-3245jnormart@w2ogroup.com
Investor ContactCourtney Dugan, W2O pure+1
(212) 257-6723cdugan@w2ogroup.com
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