Levicept Presents New Data Suggesting a Novel Neurotrophin-3 Inhibitor, LEVI-04, May Modify Disease and Improve Symptoms in Osteoarthritis

Clinical and Pharmacology Data Presented at ACR Convergence 2025

In a Phase II trial, LEVI-04 demonstrated a significant, dose-dependent reduction in bone marrow lesions (BML) compared with placebo in patients with osteoarthritis (OA)
A significant correlation between improvements in OA symptoms and positive effects on bone structure suggests disease modification potential
In newly reported pre-clinical data, there was no evidence of worsening of joint pathology with LEVI-04 treatment. LEVI-04 demonstrated improvement in joint pathology with chondroprotection, and reduced bone erosion compared to controls in an established disease model of OA
Pharmacology data presented for the first time demonstrated LEVI-04 bound all neurotrophins (NT) with highest affinity for NT-3, supporting a favourable safety profile for patients with OA

SANDWICH, United Kingdom, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis, is today reporting key new data from its large-scale Phase II trial of LEVI-04 in a plenary presentation at the American College of Rheumatology's annual meeting, ACR Convergence 2025, in Chicago, Illinois.

The new clinical data, to be presented by Simon Westbrook, Founder and CSO of Levicept, are from the company’s multi-arm, 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). Previously presented data showed the primary efficacy endpoint of the trial was met with significant analgesia and symptom control across all doses, with a favourable safety and tolerability profile.

The new data show that LEVI-04 had positive dose-dependent effects on the size and presence of bone marrow lesions, compared to placebo. These effects correlated with improvements in pain and function, suggesting LEVI-04 may have disease modification properties in addition to the analgesic properties already reported.

The pharmacology and mechanism of action of LEVI-04 will also be presented for the first time. By supplementing endogenous soluble p75 neurotrophin binding receptor, LEVI-04 binds excess neurotrophins to regulate pain pathways while maintaining essential functions. LEVI-04 bound all neurotrophins, with highest affinity for neurotrophin-3, supporting the favourable safety profile previously presented for LEVI-04 in patients with OA.

Further presentations of Phase II data show that LEVI-04 demonstrated effect sizes for pain that met or exceeded those reported for oral NSAIDs and resulted in significantly more patients achieving the minimum clinically important difference on the StEPP (a model of evoked pain on movement), compared to placebo, and at levels historically comparable or better than NSAIDs.

In a non-clinical model of OA, LEVI-04 provided analgesia and improved joint histopathology.

Simon Westbrook, Founder and CSO of Levicept, said: “We are hugely excited by the new data we are presenting at this year’s ACR Convergence that further underline LEVI-04’s potential as a breakthrough therapy in OA.

“We present new clinical 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. To our knowledge, this is first time a molecule has demonstrated both disease modification and analgesia in a clinical study.

“This is supported by compelling preclinical data on LEVI-04’s mechanism of action which demonstrate it is acting in a novel way through selective inhibition of neurotrophin-3. Furthermore, preclinical studies provide additional evidence that LEVI-04 has a positive impact on disease progression.”

Eliot Forster, CEO of Levicept, said: “We believe the data we are presenting here at ACR Convergence highlight LEVI-04’s unique profile within the OA space. We have now demonstrated, in a large clinical study and backed by compelling pharmacology data, that LEVI-04 has the potential to not only significantly reduce pain but directly address the disease process. We look forward to the further clinical development of LEVI-04 and to advancing a new treatment option to millions of patients in need worldwide.”

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

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, Dr C Mike Perkins, Bernadette Hughes, Claire Herholdt, Iwona Bombelka, Simon Westbrook

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, Dr C Mike Perkins, Claire Herholdt, Iwona Bombelka, Simon Westbrook

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.

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