Levicept Presents Positive Phase II Data for Novel Neurotrophin-3 Inhibitor, LEVI-04, at 2025 World Congress on Osteoarthritis

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• Plenary presentation of data showing primary efficacy endpoint met - significant analgesia across all doses
• Significant improvement in all signs and symptoms of osteoarthritis for all doses
• Poster presentation of imaging data showing no increase in incidence of rapid joint deterioration compared to placebo
• First-in-class novel biologic under development as non-addictive pain treatment

SANDWICH, United Kingdom, April 26, 2025 (GLOBE NEWSWIRE) -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis, is presenting key data from its positive Phase II trial of LEVI-04 at the 2025 World Congress on Osteoarthritis (OARSI) in Seoul, South Korea.

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 being presented at the conference 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).

Professor Philip Conaghan, MBBS, PhD, Director NIHR Leeds Biomedical Research Centre, Principal Investigator, has been invited to give a plenary presentation of efficacy data from the trial.

LEVI-04 demonstrated significant differences to placebo for the primary endpoint for all doses:

• The primary endpoint was WOMACⁱ pain assessment (change from baseline at Week 17).
• More than 50% of the LEVI-04-treated patients reported ≥50% reduction in pain and >35% reported ≥70% reduction at week 17.
• Secondary endpoints included WOMAC subscales of function and joint stiffness, patient global assessment and daily pain scores and these were all statistically different to placebo.
• Time to onset of analgesia of 3 to 5 days.
• LEVI-04 was well tolerated, with no emergent safety concerns.

In addition, Professor Ali Guermazi, Boston University, will present the imaging data from the study which showed that LEVI-04 was not associated with deleterious effects on joint structure. There was no increase in the observed incidence of joint-related events at any dose of LEVI-04 compared with placebo, supporting the safety of the novel NT-3 inhibition mechanism of action of LEVI-04.

Professor Philip Conaghan said, "We are excited to be presenting these truly exceptional results from a robust and well-designed study at OARSI. Safe and effective pain management is of critical importance in osteoarthritis with existing treatments limited by adverse effects, addiction liabilities and poor efficacy. LEVI-04 demonstrated significant and clinically meaningful improvement in pain, function and other outcomes.

"Also, importantly, the imaging data showed that LEVI-04 was not associated with damage to joint structure. Previous analgesic therapies selectively targeting excess neurotrophins have demonstrated analgesia but were associated with significant joint pathologies including rapidly progressive osteoarthritis. We continue to believe LEVI-04 has the potential to offer a vital new treatment option to millions of patients in need.”

Eliot Forster, CEO of Levicept, said, "The significant interest in the results of our Phase II results at the highest calibre medical conferences around the world underlines their importance. 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:

LEVI-04, a Novel Neurotrophin-3 Inhibitor, Substantially Improves Pain and Function in People with Knee Osteoarthritis: a Randomised Controlled Phase II Trial.

Authors: Conaghan, Philip G; Guermazi, Ali; Katz, Nathaniel; Bihlet, Asger R; Rom, Dror; Perkins, C Michael; Hughes, Bernadette; Herholdt, Claire; Bombelka, Iwona; Westbrook, Simon.

Presentation: Oral plenary presentation - 26 April 2025, 10:45 - 10:55 AM KST

LEVI-04, a novel neurotrophin-3 inhibitor, is not associated with deleterious effects on joint structure in people with knee osteoarthritis: data from a Phase II RCT.

Guermazi, Ali; Conaghan, Philip G; Katz, Nathaniel; Bihlet, Asger R; Rom, Dror; Perkins, C Michael; Hughes, Bernadette; Herholdt, Claire; Bombelka, Iwona; Westbrook, Simon.

Presentation: Poster #410 - 25 April and 26 April 4:15 - 5:00 PM KST

Levicept

Eliot Forster, CEO - [email protected]

Media Enquiries

Charles Consultants

Sue Charles - [email protected] +44 (0)7968 726585

Chris Gardner - [email protected] +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.

Follow us on LinkedIn - https://www.linkedin.com/company/levicept-ltd

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ⁱ The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale - a recognised standard pain scale