Levicept to Present Key New Data from Phase II Trial of LEVI-04, a Novel Neurotrophin-3 Inhibitor, at ACR Convergence 2025

September 25, 2025 |

3 min read

A significant, dose-dependent reduction in bone marrow lesion presence and area was observed for LEVI-04 compared with placebo in patients with osteoarthritis
Changes in bone marrow lesion area were significantly correlated with changes in patient-reported symptoms including pain
Further presentations detail LEVI-04 mechanism of action, functional outcomes and imaging screening exclusions
LEVI-04 is a first-in-class novel biologic under development as non-addictive pain treatment

SANDWICH, UK, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis, will be presenting key new data from its large-scale Phase II trial of LEVI-04 at the American College of Rheumatology's annual meeting, ACR Convergence 2025, being held from 24 – 29 October in Chicago, Illinois.

The new data are from Levicept's multiarm, multicentre, randomized, double-blind, placebo-controlled, Phase II study which enrolled 518 participants with pain and disability due to osteoarthritis (OA) of the knee (ClinicalTrials.gov ID: NCT05618782). Previously presented data showed the primary efficacy endpoint of the trial was met with significant analgesia across all doses, and a favourable safety and tolerability profile.

Professor Philip Conaghan, MBBS, PhD, Director NIHR Leeds Biomedical Research Centre, Principal Investigator, said, “We look forward to presenting new data from this large, robust study of LEVI-04 at ACR Convergence 2025. For the first time, we will show findings which suggest that LEVI-04 holds promise as a therapy to provide contemporaneous modification of joint structure - bone marrow lesions - and symptoms of OA including pain. We will also present an analysis of LEVI-04’s mechanism of action and further studies which we believe add to the evidence of LEVI-04’s potential to offer a vital new treatment option for millions of patients worldwide in need.”

Presentation details:

LEVI-04 Significantly Reduces Bone Marrow Lesions and Symptoms in Knee Osteoarthritis: Results from a Phase II RCT

Oral plenary presentation (0852) – Monday, 27 October, 08:45 – 09:00 CST

Authors: Simon Westbrook, Ali Guermazi and Philip Conaghan

Pharmacology of LEVI-04, a novel treatment for OA

Poster presentation (1804) Tuesday, 28 October, 10:30 – 12:20 CST

Authors: Simon Westbrook and Kerry af Forselles

Radiologic surveillance in the Phase II RCT of LEVI-04, a novel neurotrophin-3 inhibitor, in people with knee osteoarthritis: exclusions at screening

Poster presentation (2081) Tuesday, 28 October, 10:30 – 12:30 CST

Authors: Ali Guermazi, Philip Conaghan, C. Michael Perkins, Claire Herholdt, Iwona Bombelka and Simon Westbrook

LEVI-04, a Novel Neurotrophin-3 Inhibitor, Demonstrates Clinically Meaningful Improvements in Pain and Physical Function across a Range of OA Outcomes, Including the Staircase-Evoked Pain Procedure (StEPP)

Poster presentation (2101) Tuesday, 28 October, 10:30 – 12:30 CST

Authors: Philip Conaghan, Nathaniel Katz, Asger Bihlet, Laus W. Wullum, Kerry af Forselles, C. Michael Perkins, Bernadette Hughes, Claire Herholdt and Iwona Bombelka

Levicept

Eliot Forster, CEO - eliot@levicept.com

Media Enquiries

Charles Consultants

Sue Charles - Sue@charles-consultants.com +44 (0)7968 726585

Chris Gardner - Chris@CGComms.onmicrosoft.com +44 (0)7956 031077

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.