Efficacy and safety of LEVI-04 in patients with osteoarthritis of the knee: a randomised, double-blind, placebo-controlled, phase 2 trial - PubMed
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- #p75NTR
- #clinical trial
- #osteoarthritis
- LEVI-04, a p75 neurotrophin receptor (p75NTR) fusion protein inhibiting neurotrophin-3, was assessed for efficacy and safety in knee osteoarthritis patients in a phase 2 trial.
- The trial involved 518 participants randomized to placebo or LEVI-04 doses (0.3 mg/kg, 1.0 mg/kg, 2.0 mg/kg) monthly until week 16, with safety follow-up to week 30.
- Primary endpoint (change in WOMAC pain at week 17) showed significant improvements vs placebo across all doses, with p-values of 0.023, 0.015, and 0.0024 respectively.
- Effect sizes (standardized mean differences) at week 17 were 0.28, 0.33, and 0.43 for the 0.3 mg/kg, 1.0 mg/kg, and 2.0 mg/kg groups, indicating dose-dependent efficacy.
- Safety analysis revealed no increased incidence in serious adverse events, treatment-emergent adverse events, or joint pathologies like rapidly progressive osteoarthritis compared to placebo.
- Interpretation suggests LEVI-04 was well-tolerated and supports supplementing endogenous p75NTR for osteoarthritis treatment, with funding and conflicts of interest disclosed from Levicept and various pharmaceutical entities.