Lorecivivint is superior to placebo for improving pain, function, and structure at 12 months and beyond in patients with knee osteoarthritis, according to data presented at ACR Convergence 2024.
Lorecivivint (Biosplice) is an intra-articular CLK/DYRK inhibitor that may modulate inflammatory and Wnt pathways, according to the researchers. Yazici and his colleagues did a clinical trial to find out if the agent was safe and effective over the long term and if it could be used more than once on people with moderate to severe knee OA. The analysis included 276 patients with a mean age of 61 ± 8.2 years and a BMI of 31.8 ± 4.9 kg/m². The cohort was 62.7% women, with 45.3% demonstrating a Kellgren-Lawrence Grade of 3 and a medial joint space width of 2.63 ± 0.69 m. Approximately two-thirds of the cohort were bilaterally symptomatic.
Results of the trial at 1 year showed statistically significant improvements for Lorecivivint compared with placebo. For example, the study drug bested placebo in WOMAC pain at week 24 and week 48, according to the researchers. Similarly, WOMAC function improved with Lorecivivint compared with placebo at week 48. Through the crossover part of the study in year 2, the results also showed that all patients in the placebo group who switched to Lorecivivint had better pain and function.
“This is the first study to show benefit in pain, function, and structure in knee OA patients in the same study, as far as we know. In addition, patients who were on placebo showed similar improvements once they crossed over to the Lorecivivint arm, further supporting the beneficial effects of Lorecivivint.”
“Safety of Lorecivivint was consistent with what we have seen so far in our development program, with no serious adverse events related to Lorecivivint reported and an overall adverse events profile no different than placebo,” Yazici said. These findings may offer hope to patients and providers dealing with knee OA, according to Yazici.
In this and similar studies, researchers are investigating treatment methods, but the public will accept their claims when they are used by different groups of doctors on patients of different nationalities and approved by them.
- Yazici Y. Abstract #0792. Presented at: ACR Convergence 2024; Nov. 14-19, 2024; Washington, D.C