Centrexion Therapeutics to Announce CNTX-4975 Trial Results at the European League Against Rheumatism’s (EULAR) 2019 Annual...
June 11 2019 - 7:30AM
Centrexion Therapeutics Corporation, a company focused on
developing non-opioid, non-addictive therapeutics for the treatment
of chronic pain, today announced that it will report data from two
clinical studies of CNTX-4975, including an assessment of the
company’s proprietary cooling method for reducing procedural pain,
at the 2019 European League Against Rheumatism (EULAR) Annual
Conference taking place June 12-15, 2019 in Madrid, Spain.
“We are pleased to share further results from
clinical studies refining our proprietary cooling procedure
technique for intra-articular injection of CNTX-4975 for painful
knee osteoarthritis. In these studies, we have observed in patients
with knee osteoarthritis that with the use of readily available
cooling devices, such as an ice-gel pack, in an abbreviated
30-minute cooling schedule, we can effectively reduce procedural
pain,” said Randall Stevens, M.D., chief medical officer of
Centrexion. “In our ongoing Phase 3 VICTORY-3 study, we continue to
evaluate variations of the CNTX-4975 administration procedure
designed to maximize physician and patient experience and
convenience.”
Full abstracts have been published in the EULAR
Journal Annals of the Rheumatic Diseases and are available online.
Details of the abstracts and poster presentation are listed
below.
Title:
Intra-articular CNTX-4975 for Painful Knee Osteoarthritis:
Assessment of Cooling Methods for Reducing Procedural
PainTopic: 22. OsteoarthritisAbstract
Number: AB0810Online publication:
https://ard.bmj.com/content/78/Suppl_2/1875.3
Title:
Pharmacokinetics (PK) of a Single Intra-Articular (IA) Injection of
CNTX-4975 (Trans-Capsaicin) vs Topical 8% Capsaicin
PatchAbstract/Poster Number: THU0455Online
publication:
https://ard.bmj.com/content/78/Suppl_2/517.2Presentation
Time: June 13, 2019 from 11:45AM-1:30 PM
CESTLocation: Poster Area (Hall 10)
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 a repeat
dose, administered six 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).
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, eight-week trial to
evaluate the safety 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, 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-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 pain associated with knee OA.
About Centrexion
TherapeuticsCentrexion 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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