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EULAR 2017 | Daily Highlights
EFFICACY AND SAFETY OF CNTX-4975 IN SUBJECTS WITH MODERATE TO SEVERE OSTEOARTHRITIS KNEE PAIN: 24-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDYAbstract: OP0167
Authors: R. Stevens1,*, D. Petersen2, J. Ervin3, J. Nezzer4, Y. Nieves4, J. Campbell1, K. Guedes1, R. Burges1, P. Hanson1
1Centrexion Therapeutics, Boston, 2Noble Clinical Research, LLC, Tucson, 3The Center for Pharmaceutical Research, Kansas City, 4Premier Research, Durham, United States
Osteoarthritis causes joint pain, stiffness, and reduced function, leading to disability. CNTX-4975, a highly purified, synthetic trans-capsaicin, targets the transient receptor potential vanilloid 1, producing analgesia via reversible deactivation of end terminals of primary afferent pain fibers within the joint and capsule.
This 24-week dose-ranging study evaluated CNTX-4975 efficacy and safety in subjects with chronic, moderate to severe osteoarthritis-associated knee pain.
Subjects aged 45–80 years with chronic knee osteoarthritis, stable moderate to severe knee pain, and intolerability to oral or intra-articular analgesics were randomized to a single injection of placebo, CNTX-4975 0.5 mg, or CNTX-4975 1.0 mg. The primary efficacy endpoint was the area under the curve (AUC) for change from baseline in daily Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 score through week 12. Least squares mean differences (LSMD) for CNTX-4975 vs placebo were calculated for the primary endpoint and the average weekly AUC WOMAC A1 scores using analysis of covariance. Additional efficacy endpoints, mean change from baseline in weekly WOMAC A1 score, WOMAC B stiffness subscale, and WOMAC C physical function subscale through week 24, were analyzed using a mixed model for repeated measures (MMRM). Statistical tests were 2-sided (alpha, P=0.10). Safety assessments included treatment-emergent adverse events (TEAEs).
Efficacy was evaluated in 172 subjects (placebo, n=69; CNTX-4975 0.5 mg, n=33; CNTX-4975 1.0 mg, n=70). Mean WOMAC A1 pain scores at baseline were 7.4 (placebo), 7.2 (CNTX-4975 0.5 mg), and 7.2 (CNTX-4975 1.0 mg). In the primary efficacy analysis, significant improvements vs placebo in WOMAC A1 scores were observed at week 12 with CNTX-4975 0.5 mg (LSMD: -0.8; P=0.07) and CTNX-4975 1.0 mg (LSMD: -1.6; P
A single injection of CNTX-4975 1.0 mg improved pain with walking, knee stiffness, and physical function, and was well tolerated in subjects with moderate to severe osteoarthritis-associated knee pain.
Disclosure of Interest:
R. Stevens Shareholder of: Centrexion Therapeutics, Employee of: Centrexion Therapeutics, D. Petersen: None declared, J. Ervin: None declared, J. Nezzer Consultant for: Centrexion Therapeutics, Y. Nieves Consultant for: Centrexion Therapeutics, J. Campbell Shareholder of: Centrexion Therapeutics, Employee of: Centrexion Therapeutics, K. Guedes Shareholder of: Centrexion Therapeutics, Employee of: Centrexion Therapeutics, R. Burges Shareholder of: Centrexion Therapeutics, Employee of: Centrexion Therapeutics, P. Hanson Shareholder of: Centrexion Therapeutics, Employee of: Centrexion Therapeutics
In this interesting dose finding study of patients with osteoarthritis CNTX-4975, an new drug for intraarticular application, was tested against placebo.CTNX-4975 is a synthetic trans-capsaicin which ist reversible deactivating end terminals of afferent pain fibres within the joint and capsule.A single injection of CNXT-4975 1 mg improved pain, stiffness and physical function at 12 and 24 weeks compared to placebo. The lower dose of 0.5 mg only at week 12. The drug was well tolerated especially in the 1 mg dose regimen. CTNX-4975 seems to be a promising new drug for intraarticular use in patients with knee osteoarthritis. Phase III trials with a higher number of patients are under way.
Dr. Thomas Langenegger