Levicept: LEVI-04 Reduces Osteoarthritis Pain

1. Patients with chronic pain from osteoarthritis who received LEVI-04 had a 50% reduction in pain from baseline.
2. LEVI-04 was well tolerated with no increase in rapidly progressive osteoarthritis.

The Latest

A multiple-arm, multicentre, prospective, randomized, double-blind, placebo-controlled, Phase II study by Levicept evaluated the efficacy, safety, and tolerability of five monthly infusions of LEVI-04 compared with placebo. The trial recruited more than 510 patients across Europe and Hong Kong with pain and disability due to knee osteoarthritis. The primary endpoint was Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain assessment compared with baseline. At Week 17, the mean reduction in WOMAC pain scores from baseline was greater than 50% for all three doses of LEVI-04 and statistically different from the placebo. Secondary endpoints including WOMAC subscales of function and joint stiffness, patient global assessments, and daily pain scores were also found to be statistically different from placebo suggesting an overall improvement of chronic pain symptoms in these patients with radiographic and symptomatic knee osteoarthritis. Furthermore, standard safety monitoring plus peripheral nervous system assessments showed LEVI-04 to be well tolerated by participants in the trial.

Physician’s Perspective

Osteoarthritis is a disease in which the surface of joints becomes damaged. The cartilage that normally cushions the ends of bones becomes worn out over time causing stiffness and pain. According to the Centers for Disease Control and Prevention, osteoarthritis affects more than 32.5 million individuals in the US alone. In 2020, osteoarthritis was found to affect 595 million people globally, and accounting for 7.6% of the worldwide population. Osteoarthritis is the most prevalent form of arthritis. Current treatment forms for osteoarthritic pain management have poor efficacy and are severely limited by adverse effects and addiction liabilities. LEVI-04 safely harnesses analgesic properties while avoiding use-limiting side effects with its unique design.

Molecular Targets

In conditions like osteoarthritis, a substance called nerve growth factor (NGF) is high, which is thought to increase the amount of pain people feel. However, anti-NGF antibodies alone can have side effects including rapidly progressive osteoarthritis. LEVI-04 is a fully human chimeric fusion protein combining the Fc fragment of human immunoglobulin G1 with the p75 neurotrophin receptor (p75 NTR). LEVI-04 is a novel neurotrophin-3 (NT-3) inhibitor that also restores neurotrophin homeostasis and provides profound analgesia without use-limiting side effects. The molecule provides analgesia via inhibition of neurotrophin-3 while avoiding unwanted side effects of anti-NGF antibodies. By supplementing the endogenous neurotrophin receptor, LEVI-04 retains the important trophic effects of neurotrophins which includes joint remodeling.

Company History

Levicept is a UK-based biotechnology company developing the first of a new class of novel, safe, and efficacious biological therapies for the treatment of osteoarthritis and associated chronic pain. The mission of the company is to help people with chronic pain and osteoarthritis to manage their pain without the use of prolonged opioids and NSAIDs which can cause side effects.

Further Reading: https://levicept.com/trials/

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