A Phase 3, 56-week, randomised, double-blind, placebo-controlled study (OA-11) utilising patient-reported and radiographic outcomes evaluating the efficacy and safety of a lorecivivint injection in patients with moderate to severe knee osteoarthritis.
Level 2 - randomized trial
Phase 3 multicenter randomized double-blind placebo-controlled trial
PubMed 39808286 · doi:10.55563/clinexprheumatol/hjt118
What was done
In a multicenter, 56-week, double-blind, phase 3 trial, 513 patients with moderate-to-severe knee osteoarthritis (Kellgren-Lawrence grades 2-3, medial joint space width 1.5-4 mm) were randomized 1:1 to receive a single intraarticular injection of 0.07 mg lorecivivint or vehicle placebo. The primary endpoint was change from baseline in weekly average daily pain Numeric Rating Scale (NRS) at Week 12. Secondary endpoints included WOMAC Function and Pain, Patient Global Assessment, medial joint space width (JSW), and safety.
What was found
The mean change from baseline in pain NRS at Week 12 was -2.24 (±0.13) for lorecivivint versus -2.49 (±0.13) for placebo (p=0.185, 95% CI -0.12 to 0.62). Secondary clinical endpoints showed no discernible treatment benefit for lorecivivint over placebo. Neither group experienced meaningful medial JSW loss over 52 weeks. Adverse event incidence, severity, and relationship to treatment were similar between arms.
Why it matters
Lorecivivint failed to meet its primary efficacy endpoint for pain reduction and demonstrated no structural or functional benefits over placebo in this phase 3 knee osteoarthritis cohort.
Limits
Evaluated only a single dose (0.07 mg) and single-administration regimen. The abstract does not provide exact numerical data for secondary endpoints (WOMAC scores, JSW changes) or specific adverse event breakdowns.
Cited by
- contradicts Biosplice's osteoarthritis treatment is a single injection that regrows all tendons in 11 months to the state of 16-year-old tendons.