Action required: Please refresh your browser
We have recently implemented some changes that require a hard refresh of your browser: Please hold down the CTRL-key and press the F5 key.
After a successful hard refresh, this message should not appear anymore.
More details about this topic are available here »
Centrexion Therapeutics Announces Completion of Patient Enrollment in VICTORY-3 Phase 3 Open-Label Clinical Trial of CNTX-4975 in Patients with Moderate-to-Severe Osteoarthritis Knee Pain | ||
By: Nasdaq / GlobeNewswire - 17 Sep 2019 | Back to overview list |
|
- CNTX-4975 Phase 3 clinical development program fully enrolled - - VICTORY-1 pivotal and VICTORY-3 open-label topline results expected in Q1 2020; VICTORY-2 pivotal results expected in Q3 2020 - BOSTON, Sept. 17, 2019 (GLOBE NEWSWIRE) -- 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 Program 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 Osteoarthritis About CNTX-4975 About Centrexion Therapeutics Corporation Media Contact Investor Contact |
||
|
||
Copyright 2019 Nasdaq / GlobeNewswire | Back to overview list |