- Primary efficacy endpoint met – significant analgesia across all doses
- Significant improvement in all signs and symptoms of osteoarthritis for all doses
- Well tolerated with no increase in incidence of rapid joint deterioration compared to placebo
- First-in-class novel biologic under development as non-addictive pain treatment
- Oral presentation at 8am EST on 19 November
SANDWICH, United Kingdom, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis, is presenting the results from its positive Phase II trial of LEVI-04 at the American College of Rheumatology’s annual meeting, ACR Convergence 2024, being held from 14 November to 19 November, 2024 in Washington, DC. Headline results were first announced in August 2024.
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).
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).
- The mean reduction in WOMAC pain score from baseline was greater than 50% for all three doses of LEVI-04 (0.3mg/kg, 1mg/kg, 2mg/kg) and all statistically different to placebo (p<0.05 vs placebo, all doses).
- 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.
Standard safety monitoring plus peripheral nervous system assessments showed LEVI-04 to be well tolerated. There was no increased incidence of SAEs, TEAEs and joint pathologies including rapidly progressive OA compared to placebo as measured via detailed, closely examined, radiographic analysis.
Professor Philip Conaghan MBBS PhD, Director NIHR Leeds Biomedical Research Centre, Principal Investigator, who will present the data said, “We believe these are truly exceptional results from a robust and well-designed study. LEVI-04 demonstrated significant and clinically meaningful improvement in pain, function and other outcomes and was well tolerated at all doses studied.
“Safe and effective pain management is of critical importance in osteoarthritis with existing treatments limited by adverse effects, addiction liabilities and poor efficacy. These results support the concept of supplementing endogenous p75NTR as a treatment for osteoarthritis, and our belief that 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 selection of Levicept’s Phase II results as an oral presentation at ACR Convergence highlights their importance and reinforces our confidence that LEVI-04 could represent a genuine breakthrough in the treatment of osteoarthritis. We are now focused on strategic options to advance LEVI-04’s development and ensuring the best opportunity for it to reach the many patients who may benefit.”
The data will be presented Tuesday, 19 November, 2024 at 08:00 EST, abstract number L15.
Levicept
Eliot Forster, CEO – eliot@levicept.com
Media Enquiries
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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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i The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale – a recognised standard pain scale
