Centrexion reports 24-week data from Phase IIb of CNTX-4975 in OA knee pain

Centrexion Therapeutics Corp. (Boston, Mass.) reported additional data from the double-blind, U.S. Phase IIb TRIUMPH trial in 175 patients with chronic, moderate to severe osteoarthritis (OA) knee pain showing that a single intra-articular injection into the knee of 1 mg CNTX-4975 significantly reduced average daily knee pain with walking from baseline to week 24 vs. placebo. The endpoint was measured by area under the curve (AUC) and by a mixed model for repeated measures (MMRM) for scores on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 score. Specifically, 1 mg CNTX-4975 reduced average daily knee pain with walking by 3.8 points on both measures compared to 2.5 and 2.9 points, respectively, for placebo (p=0.0002 and p=0.067, respectively). TRIUMPH''s prespecified threshold for significance was p=0.1. Data were presented at the European League Against Rheumatism meeting in Madrid.

Patients received a single intra-articular injection into the knee of placebo or 0.5 or 1 mg CNTX-4975. Centrexion previously reported that both doses of CNTX-4975 met the primary endpoint of reducing average daily knee pain with walking as measured by WOMAC A1 score from baseline to week 12 vs. placebo (see BioCentury, Dec. 19, 2016). High-dose CNTX-4975 reduced pain per AUC and MMRM by 3.9 and 4.4 points, respectively, vs. 2.3 and 2.9 points for placebo (p<0.0001 and p=0.0003, respectively). High-dose CNTX-4975 also met the secondary endpoints of improving knee joint stiffness per WOMAC B score, knee joint function per WOMAC C score, Patient Global Impression of Change (PGIC) and pain response rate vs. placebo...