Levicept has announced promising results from a mid-stage study of its neurotrophin-3 (NT-3) inhibitor in patients with moderate-to-severe osteoarthritis.
The phase 2 trial has been evaluating the candidate, LEVI-04, in more than 500 patients with pain and disability due to osteoarthritis of the knee.
Osteoarthritis is the most common form of arthritis, affecting more than 32.5 million adults in the US, according to the Centers for Disease Control and Prevention.
The degenerative joint disease occurs when the protective cartilage that cushions the ends of the bones wears down over time, resulting in pain, stiffness, loss of flexibility and other symptoms.
LEVI-04 is designed to provide pain relief while avoiding the side effects of anti-NGF antibodies, including rapidly progressive osteoarthritis (RPOA), and retaining the trophic effects of the neurotrophins.
The study met its primary endpoint, demonstrating a mean reduction in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline of more than 50% for all three LEVI-04 doses,all statistically different from placebo.
The drug also showed significant differences to placebo at week 17 on all secondary endpoints, including WOMAC subscales of function and joint stiffness, as well as daily pain scores, and there was no increase in the incidence of RPOA.
Principal investigator Philip Conaghan, director of NIHR Leeds Biomedical Research Centre, said: “In this trial, LEVI-04 has demonstrated the potential to safely harness the analgesic properties of NT-3 inhibition and offer a vital new treatment option to millions of patients in huge need.
“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.”
Globally, 595 million people had osteoarthritis in 2020, affecting 7.6% of the population.
The World Health Organization announced a new collaboration with the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases last year to develop a roadmap on bone health and ageing.
The five-year agreement includes the development of a public health strategy and action plan to help prevent fractures among older people, as well as to improve the coverage of health services.