10.3.2 - Lorecivivint (SM04690): An Intra-articular Wnt Pathway Inhibitor for Knee Osteoarthritis Treatment - Phase 2b Patient-Reported Outcomes
- J. Tambiah (San Diego, US)
- Y. Yazici (San Diego, US)
- J. Bergfeld (Cleveland, US)
- M. Jones (Cleveland, US)
- C. Swearingen (San Diego, US)
- A. Difrancesco (San Diego, US)
- J. Tambiah (San Diego, US)
- S. Kennedy (San Diego, US)
- C. Lattermann (Boston, US)
Abstract
Purpose
In a 52-week study, Wnt pathway inhibitor lorecivint (SM04690) showed subgroup improvements in knee osteoarthritis (KOA) pain, function, and joint space width compared to placebo (PBO). A 24-week study was conducted to refine patient-reported outcomes (PROs), target population, and dose. PROs from Weeks 12 and 24 are presented.
Methods and Materials
KOA subjects (KL grades 2-3, Pain Numeric Rating Scale [NRS] ≥4 and ≤8 in target knee and <4 in non-target knee) received 2 mL intra-articular lorecivivint (0.03, 0.07, 0.15, 0.23 mg) or PBO/sham injection. Endpoints included change from baseline to Week 24 in weekly average of daily Pain NRS [0-10], WOMAC Pain [0-100], WOMAC Function [0-100], and Patient Global Assessment (PtGA [0-100]) compared to PBO.
Results
695 subjects were dosed. Lorecivivint appeared well tolerated. Significant improvements from baseline compared to PBO were observed in Pain NRS for 0.07 mg and 0.23 mg groups at Weeks 12 and 24 (Figure). Similar improvements were observed in WOMAC Pain, WOMAC Function, and PtGA for 0.07 mg (Week 12) and 0.23 mg (Weeks 12 and 24) dose groups.
Conclusion
Lorecivivint, a potential disease-modifying KOA drug, demonstrated significant improvements in PROs compared to PBO up to 24 weeks for 0.07 mg and 0.23 mg dose groups.