A new medication designed to relieve knee pain in osteoarthritis has shown significant promise in an international clinical trial led by researchers at the NIHR Leeds Biomedical Research Centre and the University of Leeds.
The Phase 2 trial of LEVI‑04, published in The Lancet, demonstrated substantial reductions in pain and stiffness, alongside marked improvements in patient function and overall experience of the disease. More than 500 participants with moderate to severe knee osteoarthritis were followed over a 20‑week period, with no increase in serious side effects or joint complications compared with placebo.
LEVI‑04, developed by the UK biotechnology company Levicept Ltd, is the first treatment in a new class of osteoarthritis therapies. The drug works by inhibiting neurotrophin‑3, a protein involved in transmitting pain signals in the body.
Current treatments for knee osteoarthritis are limited, often providing only partial relief or carrying risks of gastrointestinal, cardiovascular or joint‑related side effects. As the condition becomes increasingly prevalent due to ageing populations, the need for safe and effective therapies is urgent.
Trial results suggest LEVI‑04 could offer meaningful and sustained symptom relief for millions of patients worldwide.
The study was led by Professor Philip Conaghan, Director of the NIHR Leeds BRC, Professor of Musculoskeletal Medicine at the University of Leeds and Honorary Consultant Rheumatologist at Leeds Teaching Hospitals NHS Trust.
Professor Conaghan has long been a global authority in osteoarthritis research, advocating for improved treatment pathways and patient‑centred care.
Commenting on the trial, Professor Conaghan said:
“The potential benefits of this treatment for patients are very significant. Osteoarthritis impacts on all aspects of people’s lives and there are limited therapy options currently to manage the symptoms. This has left us and our patients with very few choices to relieve the discomfort caused by the condition.
“LEVI-04 as the first in a new line of therapies offers the possibility to be a game-changer, giving us better options to treat the pain faced by patients, and with further possibilities to unlock new treatments in the future. It also offers us as a chance to improve wellbeing, reduce the cost of support patients need from health services, and giving patients hope of being able to live more independently.”
Key findings from the 20‑week trial include:
- Significant reductions in knee pain
- Improved mobility and function
- Reduced stiffness
- No increase in serious adverse events compared with placebo
- No heightened risk of joint damage
These results position LEVI‑04 as a potentially transformative option for osteoarthritis care, pending further Phase 3 trials and regulatory review.
Osteoarthritis is one of the world’s most common chronic conditions and a leading cause of disability. It places substantial pressure on healthcare systems and has severe impacts on quality of life, mobility and independence.
As populations age, cases are expected to rise, making the development of safe and effective therapies a global priority.
The successful trial marks a major milestone in the search for alternatives to painkillers, injections and joint surgery, offering hope for millions living with osteoarthritis pain.
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