- Significant improvements in pain, function and patient global outcomes demonstrated
- LEVI-04 well tolerated and exhibits a favourable safety profile
SANDWICH, United Kingdom, March 30, 2026 (GLOBE NEWSWIRE) -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis (OA), today announces the publication in The Lancet of positive results of its Phase II study of LEVI-04 in patients with pain and disability due to OA of the knee [LANCET17736]1.
The trial was a multi-arm, International, multicentre, randomized, double-blind, placebo-controlled, Phase II study which enrolled 518 participants with pain and disability due to OA of the knee (ClinicalTrials.gov ID: NCT05618782).
Professor Philip Conaghan MBBS PhD, Director NIHR Leeds Biomedical Research Centre, Chief Investigator of the study and lead author of The Lancet publication 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.”
LEVI-04 demonstrated significant differences to placebo for the WOMACi pain score primary endpoint for all doses. Additionally, significant improvements with LEVI-04 were observed across secondary endpoints, including patient-reported function, stiffness, and Patient Global Assessment. Responder analyses confirmed the clinical meaningfulness of the reductions in pain, with more than half the patients treated with LEVI-04 reporting a 50% reduction in pain, and more than a quarter reporting a 75% reduction in pain.
LEVI-04 was well tolerated with no observed safety concerns. Incident rates of treatment-emergent adverse events were similar in the active treatment and placebo groups. The incidence of joint pathologies was not increased, with a low number of events recorded across the treatment and placebo groups.
Headline results were first presented at ACR Convergence, 2024ii. Further data analysis shared at ACR Convergence, 2025 has shown that LEVI-04 had positive dose-dependent effects on the size and presence of bone marrow lesions compared to placebo, suggesting LEVI-04 may have disease modification properties in addition to the analgesic properties already reportediii.
Simon Westbrook, Founder and CSO 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 OA. As shown in The Lancet publication, LEVI-04 significantly reduces pain and symptoms of OA. Separately, we have also demonstrated potential to directly address the OA 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 OA.
“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 OA 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 is published in The Lancet and is available here: Efficacy and safety of LEVI-04 in patients with osteoarthritis of the knee: a randomised, double-blind, placebo-controlled, phase 2 trial - ScienceDirect
Reference: Conaghan P, et al. LANCET Volume 407, Issue 10535, 28 March–3 April 2026, Pages 1237-1248
Levicept
Eliot Forster, CEO - eliot@levicept.com
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About Levicept – www.levicept.com
Levicept Ltd is a UK-based biotechnology company developing the first in a new class of novel, safe and efficacious biological therapies, LEVI-04 [p75NTR-Fc], for the treatment of osteoarthritis and chronic pain. LEVI-04 inhibits NT-3, one of the neurotrophin family of proteins. LEVI-04 has completed a Phase II clinical trial in more than 500 patients with osteoarthritis. It is estimated that the market opportunity for drugs that treat osteoarthritis is worth in excess of $10 billion. LEVI-04 was discovered by Levicept’s founder, Simon Westbrook. Levicept’s investors include Medicxi, Advent Life Sciences, Gilde Healthcare and Pfizer Ventures.
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About NIHR Leeds Biomedical Research Centre
The National Institute for Health and Care Research (NIHR) Leeds Biomedical Research Centre (BRC) is part of Leeds’ £40m research infrastructure, hosted by Leeds Teaching Hospitals NHS Trust with the University of Leeds and University of York.
The NIHR Leeds BRC brings together leading clinical and academic expertise to translate discoveries into new treatments, diagnostics, and health technologies across six themes: Antimicrobial Resistance and Infection, Cardiometabolic Disease, Haematology, Musculoskeletal Disease, Pathology, and Surgical Technologies. Its work involves patients and the public in research design and supports the training of the next generation of researchers.
Backed by £21.76 million in funding for 2022 to 2028, the centre is part of a national network of BRCs that accelerates the adoption of early-phase discoveries, turning innovative research into tangible improvements in healthcare that benefit both the local and national economy.
About The NIHR
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
- Funding high quality, timely research that benefits the NHS, public health and social care;
- Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
- Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
- Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
- Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK international development funding from the UK government.
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i The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale – a recognised standard pain scale
ii Conaghan P, et al. Arthritis Rheumatol. 2024;76 (suppl 9)
iii Westbrook S, et al. Arthritis Rheumatol. 2025; 77 (suppl 9)
