LEVI-04 Promising for Relieving Knee OA Pain

In an international, phase 2 clinical trial, LEVI-04 met all primary and secondary efficacy end points at all evaluated doses (NCT05618782) in patients with moderate to severe osteoarthritis (OA) of the knee (n=510), with some study patients experiencing a greater than 50% reduction in pain from baseline.^1,2

LEVI-04 is a proprietary p75 neurotrophin receptor fusion protein (p75NTR-Fc). Neurotrophins are a family of proteins that regulate the growth, survival and function of neurons in the central nervous system. LEVI-04 provides pain management via the inhibition of NT-3 activity, returning neurotrophin homeostasis by augmenting the endogenous p75NTR binding protein to scavenge excess neurotrophins existing in chronic pain conditions.¹

LEVI-04 is currently in phase 2 clinical trials to evaluate it as a treatment for OA pain and other pain-related conditions.

The Research

In this multi-arm, randomized, double-blind study, participants were 40–80 years old with a body mass index of ≤40 kg/m². These patients also had to have a history of knee pain on most days for at least three months prior to screening. The study’s primary end point was the change from baseline of the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain assessment. Patients in the LEVI-04 treatment group received either a 0.3 mg/kg intravenous (IV) infusion of LEVI-04, a 1 mg/kg IV infusion or 2 mg/kg IC infusion. Patients in the control group received an IV infusion of placebo.

At week 17, significant differences were noted between the LEVI-04 and placebo groups (P values not reported). The mean reduction in WOMAC pain score from baseline was greater than 50% for all three doses of LEVI-04 and all statistically different from placebo.

The study’s secondary end points were the WOMAC subscales for physical function, joint stiffness, and change in patient global assessment and daily pain scores. Peripheral nervous system assessments and standard safety monitoring showed that LEVI-04 was well tolerated. Additionally, no increase in incidence of rapid joint deterioration was observed compared with placebo.

Full study results are planned for release in an upcoming peer-reviewed journal (unspecified). Future clinical trials are currently in process.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Levicept announces positive results of phase 2 trial of novel neurotrophin-3 inhibitor, LEVI-04, for the treatment of patients with moderate to severe osteoarthritis [news release]. GlobeNewswire. 2024 Aug 6.
2. Clinical trial to evaluate the efficacy and safety of LEVI-04 in patients with osteoarthritis of the knee [NCT05618782]. ClinicalTrials.gov. 2024 Mar 31.