Centrexion Therapeutics Announces Completion of Patient Enrollment in Pivotal Phase 3 Clinical Trial of CNTX-4975 for the Tre...
December 05 2018 - 7:30AM
Centrexion Therapeutics Corporation, a company focused on
developing non-opioid, non-addictive therapeutics for the treatment
of chronic pain, today announced completion of patient enrollment
ahead of schedule in its pivotal Phase 3 VICTORY-1 trial, a
randomized, double-blind, placebo-controlled, 325-patient, 52-week
clinical trial to evaluate the safety and efficacy of a single
intra-articular injection of CNTX-4975 in subjects with chronic
moderate-to-severe knee osteoarthritis (OA) pain. Topline results
from VICTORY-1 are expected to be reported in the first quarter of
2020.
CNTX-4975 is an ultra-pure, synthetic form of trans-capsaicin
that is injected directly into the joint where the pain stimulus
originates. It is designed to harness the natural analgesic power
of capsaicin through a proprietary injectable therapeutic candidate
intended to provide durable pain relief within days of
administration. CNTX-4975 is designed to induce a localized
degeneration of pain sensing fibers without affecting other sensory
nerve fibers. 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.
“The completion of patient enrollment in VICTORY-1 is an
important milestone not only for Centrexion, but also for patients
with chronic knee OA pain who seek better treatment options,” said
Jeffrey B. Kindler, chief executive officer of Centrexion
Therapeutics. “VICTORY-2, the second pivotal trial which includes
repeat dosing, is also underway, with site initiation and
enrollment progressing as anticipated. The OA-303 open label,
eight-week study in 850 subjects is enrolling on schedule and we
expect to have topline results reported in 2019.”
Randall Stevens, M.D., chief medical officer of Centrexion,
said, “We have designed the OA-303 study to provide additional
information beyond just fulfilling the required safety database.
The study design includes efficacy readouts in additional patient
populations such as injection of CNTX-4975 in both knees in
patients with bilateral knee OA pain and patients with prior knee
joint replacement in the non-index knee. It will also evaluate
variations of the CNTX-4975 administration procedure designed to
enable physicians to select options that best fit their practice
dynamics and patient needs.”
About the Pivotal Phase 3 VICTORY-1 TrialThe
pivotal Phase 3 trial is a randomized, double-blind,
placebo-controlled, 52-week study to evaluate the safety and
efficacy of a single injection of CNTX-4975 in people with chronic
moderate to severe OA knee pain. The primary endpoint of the study
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.
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 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. Centrexion’s
website address is http://www.centrexion.com.
ContactJulie Normart, W2O pure +1 (628)
213-3375jnormart@w2ogroup.com
Courtney Dugan, W2O pure+1 (212) 257-6723
cdugan@w2ogroup.com
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