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A Phase 2 randomized controlled trial of LEVI-04, a neurotrophin-3 inhibitor, demonstrated significant pain reduction and functional improvement in knee osteoarthritis patients. The UK-developed intravenous treatment showed efficacy across multiple doses, with pain relief occurring as early as two weeks post-treatment and maintained through week 20, without evidence of rapidly progressive OA or significant adverse events.
Key Points:
- The trial enrolled 518 participants (mean age 63.1-65.6 years, mean BMI 29.3-30.3) randomized to receive placebo or LEVI-04 at doses of 0.3 mg/kg, 0.1 mg/kg, or 2 mg/kg over 16 weeks, with safety monitoring through week 30
- More than 50% of LEVI-04-treated patients achieved a 50% or greater reduction in pain, while more than 25% reported a 75% or greater reduction at weeks 5 and 17
- All three LEVI-04 doses demonstrated statistical significance (P < 0.05 vs placebo) for both primary and secondary endpoints, including function and patient global assessment
- Treatment-emergent adverse events showed no dose-response relationship, with infection rates of 22.5-27.1% in treatment groups compared to 34.1% in placebo, primarily consisting of minor upper respiratory infections
- The developer, Levicept, plans to advance to Phase 3 trials and aims to eventually offer the treatment as a subcutaneous self-administered formulation
“If we can help people control their pain adequately, with a therapy that’s different than an NSAID, I think we’ve got a new important therapy for a large number of people in the world.”
– Dr. Philip Conaghan, Rheumatologist and Professor of Musculoskeletal Medicine, University of Leeds
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