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BOSTON, June 11, 2019 (GLOBE NEWSWIRE) -- 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 Pain
Topic: 22. Osteoarthritis
Abstract Number: AB0810
Online 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 Patch
Abstract/Poster Number: THU0455
Online publication: https://ard.bmj.com/content/78/Suppl_2/517.2
Presentation Time: June 13, 2019 from 11:45AM-1:30 PM CEST
Location: Poster Area (Hall 10)
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 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.
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.
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.
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