NIHR Leeds BRC has played a pivotal role in the successful Phase II trial of LEVI-04, a new drug for osteoarthritis of the knee.
Professor Philip Conaghan, Director of the Leeds BRC, served as the Principal Investigator for the study conducted in collaboration with Levicept Ltd, a biotechnology company. The study took place across multiple centres in Europe and Hong Kong and involved over 510 participants with knee osteoarthritis.
Patients experienced more than a 50% reduction in pain at 17 weeks, alongside improvements in joint function and stiffness, all statistically superior to the placebo group. The study indicated no increase in incidence of rapid joint deterioration compared to placebo.
Professor Philip Conaghan, Director NIHR Leeds Biomedical Research Centre and Principal Investigator said, “These results are truly exceptional and clinically meaningful in their extent. Safe and effective pain management is of critical importance in arthritis with existing treatments limited by adverse effects, addiction liabilities and poor efficacy. In this trial, LEVI-04 has demonstrated the potential to safely harness the analgesic properties of neurotrophin-3 inhibition and offer a vital new treatment option to millions of patients in huge need. If Phase III trials replicate these results, LEVI-04 would represent a major break-through 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 and making it the most common form of arthritis. It is estimated that the market opportunity for drugs that treat osteoarthritis is worth more than $10 billion.
The full results of this trial are expected to be submitted for publication in a peer-reviewed journal.