SANDWICH, UK, June 3, 2026
Levicept Ltd announced new data from its Phase 2 clinical trial of LEVI-04, a first-in-class neurotrophin-3 (NT-3) inhibitor, demonstrating the potential to both relieve symptoms and modify disease progression in patients with knee osteoarthritis (OA). The findings are being presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress in London. The data build upon previously reported efficacy results and suggest that LEVI-04 may address underlying disease mechanisms while delivering meaningful improvements in pain and physical function. The study enrolled 518 patients with pain and disability caused by knee osteoarthritis and represents one of the largest clinical evaluations of a novel biologic therapy targeting NT-3 in OA.
MRI Data Suggest Potential Disease Modification
One of the most significant findings presented at EULAR involves the impact of LEVI-04 on bone marrow lesions (BMLs), which are commonly observed in osteoarthritis and are associated with pain severity, disease progression, and structural joint damage. Using MRI assessments, researchers observed significant dose-dependent reductions in both the presence and area of bone marrow lesions among patients receiving LEVI-04 compared with placebo. Investigators also found that reductions in BML burden were associated with improvements in patient-reported symptom scores. These findings suggest that LEVI-04 may not only reduce pain but could also influence biological processes driving osteoarthritis progression, potentially positioning the therapy as a disease-modifying treatment in a field where few therapeutic options have demonstrated such potential.
Strong Efficacy Across Pain and Functional Outcomes
Additional analyses presented at the congress highlighted clinically meaningful improvements across multiple efficacy measures. LEVI-04 demonstrated improvements in pain reduction, physical function, and responder outcomes based on established osteoarthritis assessment criteria. Researchers reported effect sizes comparable to or exceeding those commonly observed with nonsteroidal anti-inflammatory drugs (NSAIDs), a standard treatment option for osteoarthritis symptoms. The results reinforce previous findings published in The Lancet and provide further evidence supporting LEVI-04’s therapeutic potential in patients suffering from chronic pain and mobility limitations associated with knee osteoarthritis. Investigators believe the treatment’s unique mechanism may offer an alternative approach to symptom management while addressing unmet clinical needs.
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Differentiated Safety Profile Supports Continued Development
Levicept also presented comparative safety analyses evaluating LEVI-04 against fasinumab, an anti-nerve growth factor (anti-NGF) therapy previously investigated in osteoarthritis. The comparison highlighted differences in joint safety outcomes, supporting the distinct mechanism of action of LEVI-04 through NT-3 inhibition rather than NGF blockade. Researchers emphasized that the therapy may provide efficacy benefits without some of the safety concerns historically associated with anti-NGF approaches. Company executives noted that LEVI-04 remains the only therapy to demonstrate evidence suggesting both disease modification and analgesic activity in a clinical osteoarthritis study. With positive Phase 2 data now presented across efficacy, imaging, pharmacology, and safety endpoints, Levicept believes LEVI-04 could represent a significant advancement in the treatment of osteoarthritis and chronic pain conditions.
Source: Levicept press release
