VIENNA — Encouraging primary or secondary analyses of trial data for the use of several novel injectables and gene therapy for knee osteoarthritis were reported at theOther notable presentations of data from trials of investigational agents for knee OA included an update from the SPRINGBOARD phase 2B trial of EP-104IAR, a novel long-acting formulation of the corticosteroid fluticasone propionate; a phase 2 trial of, a non-opioid, semi-synthetic xylose-based polysaccharide; and an update on...
Although the changes were only numerically and not statistically different from placebo when looking at the total study population, Pavesio noted that a key objective of the trial had been to identify populations of patients that may benefit. When they looked at the effects of PTP-001 solely in those with unilateral knee OA, WOMAC pain scores were decreased to a significantly greater extent with both the high and low doses of PTP-001 vs placebo. Decreases in the least squares mean change in WOMAC pain from baseline to week 26 were 26.8 with 100-mg PTP-001, 36.1 with 200-mg PTP-001, and 24.0 with placebo .
However, it was noted that 17% of the patients in the trial had a baseline WOMAC pain score of less than 8, so the new analysis focused on a modified intention-to-treat population of 210 patients who had baseline WOMAC pain scores of 9 or higher. Two injections of XT-150 at a dose of 0.45 mg were found to produce the best effect on WOMAC pain, with a LSM change from baseline of −4.09 vs −2.74 for a single 0.45-mg injection was funded by Bioventus. Pavesio is an employee of Doron Therapeutics, a subsidiary of Bioventus. The SPRINGBOARD trial with EP-104IAR was funded by Eupraxia Pharmaceuticals. Helliwell is an employee and stockholder of Eupraxia Pharmaceuticals. The trial of PPS was funded by Paradigm Biopharmaceuticals.
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