Lorecivivint shows long-term benefits for severe knee OA

Lorecivivint showed potential benefit in radiographic and pain outcomes in an ongoing phase 3 extension trial in subjects with severe knee osteoarthritis (OA). Multiple injections appear to be a safe and effective treatment option.

Lorecivivint is a novel, intra-articular dual-specific tyrosine phosphorylation-regulated kinase (DYRKs)/CDC-like kinase (CLK) inhibitor. It is thought to modulate Wnt inflammatory and structural pathways at the nuclear level. Prof. Timothy McAlindon (Tufts University School of Medicine, MA, USA) emphasised that although there was not much change in medial joint space width (JSW) in the parent study, the STRIDES-X-ray trial, the extension was planned as there were significant findings concerning pain.

In this ongoing, single-blind, phase 3, long-term extension study (NCT04520607), 277 participants (about 50% of those who completed the parent trial) with structurally advanced knee OA (JSW of 1.5–4 mm) were enrolled [1]. At the beginning of the extension study, participants received a repeat injection according to the initial randomised treatment of either lorecivivint or placebo. At month 24 and annually thereafter, participants received an injection of 0.07 mg of lorecivivint.

The primary outcome measures consisted of medial JSW and pain Numerical Rating Scale (NRS). A potential benefit of lorecivivint compared with placebo in medial JSW was observed by month 24, with additional benefit following the third injection evident at month 36. At this time, a significant difference between active treatment and placebo at 24 months was noted, supporting the potential treatment effects of lorecivivint. Similarly, improvements in pain NRS were seen at month 36.

After 24 months, lorecivivint-treated participants also showed significant improvements in Western Ontario McMaster University Osteoarthritis Index (WOMAC) pain, assessed as a secondary endpoint. However, there was no difference at 36 months.

The compound remained safe and well tolerated, consistent with its previously observed safety profile.

1. Yazici Y, et al. Radiographic and pain outcomes from a phase 3 extension study evaluating the safety and efficacy of lorecivivint in subjects with severe osteoarthritis of the knee (OA-07): Single blind and crossover OP0074, EULAR 2023, 31 May–3 June, Milan, Italy.

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Posted on 31 July 202317 May 2024