Levicept Ltd, a UK-based biotechnology company, announced positive results from its Phase 2 trial of LEVI-04, a novel, non-opioid drug for osteoarthritis pain. The study, involving 518 patients with moderate-to-severe osteoarthritis of the knee, demonstrated significant pain reduction compared to placebo.
The trial's primary endpoint, the change from baseline on WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain scores at week 17, was met with statistically significant improvements across all three doses of LEVI-04 tested (0.3mg/kg, 1mg/kg, 2mg/kg) (p<0.05 vs placebo, all doses). Patients treated with LEVI-04 reported a mean reduction in WOMAC pain score from baseline greater than 50%. Secondary endpoints, including WOMAC subscales of function and joint stiffness, patient global assessment, and daily pain scores, also showed statistically significant differences compared to placebo.
Novel Mechanism of Action
LEVI-04 is a proprietary p75 neurotrophin receptor fusion protein (p75NTR-Fc) that inhibits neurotrophin-3 (NT-3) activity. This mechanism supplements the endogenous p75NTR binding protein and modulates excess neurotrophin levels present in osteoarthritis, offering a novel approach to pain management.
Safety and Tolerability
Importantly, LEVI-04 was well-tolerated in the trial, with no increased incidence of serious adverse events or rapid joint deterioration compared to placebo, as confirmed by radiographic analysis. This finding addresses previous safety concerns associated with other biologic approaches to chronic pain, such as nerve growth factor (NGF) inhibitors.
Expert Commentary
"We believe these are truly exceptional results from a robust and well-designed study," said Professor Philip Conaghan, Director of the NIHR Leeds Biomedical Research Centre and principal investigator of the trial. "LEVI-04 demonstrated significant and clinically meaningful improvement in pain, function and other outcomes and was well tolerated at all doses studied."
Conaghan added, "If phase 3 trials replicate these results, LEVI-04 would represent a major breakthrough for osteoarthritis treatment, and with substantial potential in other pain indications."
Future Development
Levicept is currently assessing strategic options for advancing LEVI-04's development, including potential partnerships. The company intends to explore subcutaneous administration of LEVI-04 in later-stage development. According to Levicept CEO Eliot Forster, the company intends to focus on osteoarthritis for the time being, with a label expansion into other pain settings coming after an initial approval in that indication.
Market Opportunity
The market for osteoarthritis treatments is estimated to be worth in excess of $10 billion, highlighting the significant unmet need for safe and effective pain management options. LEVI-04 represents a promising new approach that could offer a vital treatment option to millions of patients.
