Levicept's LEVI-04, a novel neurotrophin-3 (NT-3) inhibitor, has shown promising results in a Phase II clinical trial for the treatment of osteoarthritis pain. The multi-center, randomized, double-blind, placebo-controlled study, which involved over 510 patients across Europe and Hong Kong, demonstrated a significant reduction in pain and improved joint function compared to placebo.
The trial focused on patients with pain and disability due to knee osteoarthritis. Participants received five monthly infusions of LEVI-04 at various doses. The primary endpoint, measured by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain assessment, revealed a mean reduction in WOMAC pain scores from baseline exceeding 50% at Week 17 for all three LEVI-04 dose groups. This reduction was statistically significant compared to the placebo group.
Secondary Endpoint Success
Beyond the primary endpoint, LEVI-04 also demonstrated statistically significant improvements in secondary endpoints, including WOMAC subscales for function and joint stiffness, patient global assessments, and daily pain scores. These findings suggest a comprehensive improvement in chronic pain symptoms for patients with radiographic and symptomatic knee osteoarthritis.
Safety and Tolerability
Safety monitoring, including peripheral nervous system assessments, indicated that LEVI-04 was well-tolerated by the trial participants. Notably, there was no observed increase in rapidly progressive osteoarthritis, a concern associated with some other osteoarthritis treatments.
The Science Behind LEVI-04
Osteoarthritis, a prevalent condition affecting over 32.5 million individuals in the US and 595 million globally in 2020, involves the degradation of joint surfaces, leading to pain and stiffness. Current treatments often have limited efficacy and are associated with adverse effects and addiction risks. LEVI-04 offers a novel approach by targeting nerve growth factor (NGF) indirectly. In osteoarthritis, NGF levels are elevated, contributing to increased pain. While anti-NGF antibodies can alleviate pain, they may also cause rapidly progressive osteoarthritis.
LEVI-04 is a fully human chimeric fusion protein that combines the Fc fragment of human immunoglobulin G1 with the p75 neurotrophin receptor (p75 NTR). It inhibits neurotrophin-3 (NT-3) and restores neurotrophin homeostasis, providing analgesia without the side effects associated with anti-NGF antibodies. By supplementing the endogenous neurotrophin receptor, LEVI-04 retains the important trophic effects of neurotrophins, including joint remodeling.
Levicept's Mission
Levicept, a UK-based biotechnology company, is dedicated to developing safe and effective biological therapies for osteoarthritis and associated chronic pain. Their goal is to provide patients with alternatives to long-term opioid and NSAID use, which can lead to significant side effects.
