Levicept to Present Further Analysis from Phase II Trial of Novel Neurotrophin-3 Inhibitor, LEVI-04, at EULAR

Significant and clinically meaningful improvement in pain, function, and other outcomes in people with knee osteoarthritis
Rapid onset of action observed
Improvement in function out of proportion to pain-relieving effects
First-in-class novel biologic under development as non-addictive pain treatment

SANDWICH, United Kingdom, June 12, 2025 (GLOBE NEWSWIRE) -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis, is to present new data from its large-scale Phase II trial of LEVI-04 at EULAR, the European Congress of Rheumatology in Barcelona, Spain.

LEVI-04 is a proprietary p75 neurotrophin receptor fusion protein (p75NTR-Fc) that provides analgesia via inhibition of NT-3 activity, supplementing the endogenous p75NTR binding protein and modulating excess neurotrophin levels present in osteoarthritis.

The 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 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.

The further analyses for the first time show the effect sizes associated with LEVI-04 treatment and that significant and clinically meaningful improvements were observed versus placebo across a wide range of pain, function, and other outcome measures. The data also show that improvement in pain was observed after three days. Professor Philip Conaghan MBBS PhD, Director NIHR Leeds Biomedical Research Centre, Principal Investigator will present the findings in an oral presentation on June 14.

Levicept has also presented data at the conference showing that LEVI-04’s effect on physical function on both subjective and performance-based measures was disproportionately higher than expected from the reduction in pain it provides, in comparison to other treatments for knee osteoarthritis. This presentation included data from a novel model of evoked pain on movement (StEPPⁱ) which was shown to correlate well with other assessments typically used in OA trials, and where LEVI-04 performed significantly better than placebo.

Professor Philip Conaghan MBBS PhD, Director NIHR Leeds Biomedical Research Centre, Principal Investigator said, “These new data we are presenting at EULAR further support our belief that LEVI-04 has the potential to offer a vital new treatment option to millions of patients in need. The results suggest that LEVI-04 meaningfully improves physical function and pain in people with knee osteoarthritis, with rapid onset of action, vitally important treatment characteristics, and furthermore that LEVI-04 has an impact on function greater than would be expected from its impact on pain alone.”

Eliot Forster, CEO of Levicept, said, “We continue to see significant interest in the results from our Phase II study at the high calibre international medical conferences, underlining their importance, and are excited to present these additional analyses here. We are confident that LEVI-04 could represent a genuine, and much needed, breakthrough in the treatment of osteoarthritis. We continue to advance our strategy for LEVI-04’s further development and for ensuring the best opportunity for it to reach the many patients who may benefit.”

Presentation details:

Clinical Meaningfulness of Pain Improvements and Time to Onset of Pain Relief of a Novel OA Therapy: Analyses from a Randomised Controlled Phase 2 Trial with LEVI-04, a Novel Neurotrophin-3 Inhibitor

Oral plenary presentation (OP0374) – Saturday, 14 June, 13:00 - 13:10 CEST

Authors: Philip G. Conaghan, Nathaniel Katz, Asger R. Bihlet, Laus Wullum, Kerry af Forselles, Michael Perkins, Bernadette Hughes, Claire Herholdt, Iwona Bombelka, Simon Westbrook

LEVI-04, a Novel Neurotrophin-3 Inhibitor, Improves Physical Function Out of Proportion to its Pain-Relieving Effects

Poster presentation (POS0556) Wednesday, 11 June, 15:30 - 16:30 CEST

Nathaniel Katz, Simon Westbrook, Asger R. Bihlet, Laus Wullum, Kerry af Forselles, Michael Perkins, Bernadette Hughes, Claire Herholdt, Iwona Bombelka, Philip G. Conaghan

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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ⁱ StEPP – Staircase Evoked Pain Procedure - patients walk up and down a single stair 24 times in a standardised protocol, rating their pain intensity at the end (performance-based measure with no recall)

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