Researchers at the NIHR Leeds Biomedical Research Centre (BRC) and the University of Leeds have led a successful breakthrough trial of a new medication aimed at relieving knee pain in osteoarthritis.
The Phase 2 international clinical trial of LEVI-04 published in The Lancet demonstrated significant reductions in pain and stiffness, with substantial improvement in function and patients’ experience of their disease.
LEVI-04 is the first in a new class of therapies for osteoarthritis, developed by Levicept Ltd a UK-based biotechnology company. LEVI-04 inhibits neurotrophin-3, one of a family of proteins which transmit pain signals.
Osteoarthritis causes huge discomfort for people living with the condition, and puts pressure on healthcare systems, challenges that are expected to grow as the number of people with the condition rises with ageing populations.
The successful trial of LEVI-04 has potential to bring much needed relief for patients, as previously few effective therapies have been available to manage the symptoms of knee pain in osteoarthritis without causing additional complications.
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, was Chief Investigator for the study.
He 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.”
The international trial of LEVI-04 included over 500 participants with moderate to severe knee osteoarthritis studied over 20 weeks. Patients treated with LEVI-04 experienced no increase in serious side effects or joint problems compared with placebo.
Dr Simon Westbrook, founder and Chief Scientific Officer of Levicept and senior author of The Lancet publication said:
“We are hugely proud to have had our study selected for publication in The Lancet. We believe LEVI-04 has a unique profile as a new treatment option for osteoarthritis. As shown in The Lancet publication, LEVI-04 significantly reduces pain and symptoms of osteoarthritis.
“Separately, we have also demonstrated potential to directly address the osteoarthritis disease process. We believe it is the only molecule to have demonstrated both analgesia and the potential for disease modification in a clinical study in patients with osteoarthritis.
“I would like to thank our investigators, all those involved in the study, and most importantly the participants. We now concentrate on further advancing the clinical development of LEVI-04 as new treatment options for millions of patients with osteoarthritis in need worldwide.”
The article, Efficacy and safety of LEVI-04 in patients with osteoarthritis of the knee: a randomised, double-blind, placebo-controlled, phase 2 trial (Reference: LANCET17736), is published in The Lancet now and is available here: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00131-5/fulltext