CNTX Context Therapeutics Inc

Centrexion Therapeutics Corporation (Centrexion), a company focused on developing non-opioid, non-addictive therapeutics for the treatment of chronic pain, today announced that a paper presenting the results from the Phase 2 TRIUMPH clinical trial of CNTX-4975 (trans-capsaicin) injection for the treatment of moderate to severe knee pain associated with osteoarthritis (OA) has been published online in the journal Arthritis & Rheumatology. The final article will be available in the forthcoming print issue of Arthritis & Rheumatology.

In the randomized, double-blind, placebo-controlled TRIUMPH study, the data showed that a single 1 mg intra-articular injection of CNTX-4975 produced a significant decrease in knee OA pain through 12 and 24 weeks (p<0.0001 and p=0.0002 respectively). Treatment-emergent adverse events observed in the treatment arm were similar to those observed in placebo. Further, the publication provides details regarding Centrexion’s proprietary cooling procedure technique, which is designed to provide patient comfort and enables Centrexion to conduct blinded clinical trials. Centrexion has filed a patent application covering this technique.

Centrexion expects to present findings from additional studies of CNTX-4975 and the cooling procedure technique in May at the Osteoarthritis Research Society International (OARSI) 2019 World Congress, where four posters have been accepted for presentation.

“We’re pleased to have these data published in a peer-reviewed journal, as this is the first occasion where we have publicly provided the cooling procedure technique used in our clinical trials,” said Dr. Randall Stevens, Chief Medical Officer of Centrexion. “We are currently conducting additional clinical studies designed to shorten the technique for optimal clinical use in patients. We look forward to presenting these studies at the OARSI World Congress in May.”

“Joint pain due to osteoarthritis is increasingly common as our communities grow older. Apart from muscle strengthening, we have few proven therapies to reduce pain, with most associated with substantial side effects,” said Dr. Philip Conaghan, Professor of Musculoskeletal Medicine, University of Leeds. “These early data on CNTX-4975—which uses an injection of capsaicin in knee OA—give us hope that we may have a new potential therapy. The capsaicin is designed to work selectively on pain fibers, and the study showed a dose-related reduction in joint pain, which lasted for six months after injection. This work has laid the foundation for the current larger Phase 3 trials to fully assess the potential benefits of this new therapeutic candidate.”

About OA OA is the most common joint disease in the United States, 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-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 CentrexionCentrexion 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.

Deshpande, B., et al. Number of Persons With Symptomatic Knee Osteoarthritis in the US: Impact of Race and Ethnicity, Age, Sex, and Obesity. Arthritis Care & Research. Published online November 3, 2016

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