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Levicept's LEVI-04 Demonstrates Promising Phase II Results for Knee Osteoarthritis

• Levicept's LEVI-04, a novel p75NTR-Fc fusion protein, shows substantial improvements in pain and function for knee osteoarthritis patients in Phase II trial. • The Phase II study enrolled 518 participants and demonstrated that LEVI-04 provides analgesia by inhibiting NT-3 activity and restoring neurotrophin homeostasis. • Data from the randomized, double-blind, placebo-controlled trial will be presented at ACR Convergence 2024 on November 19th, highlighting the potential of LEVI-04 as a new treatment option. • LEVI-04 targets the underlying mechanisms of osteoarthritis pain, offering a potentially safer and more effective alternative to existing treatments with limited efficacy and adverse effects.

Levicept Ltd will present Phase II trial results for LEVI-04, a first-in-class treatment for osteoarthritis, at the American College of Rheumatology's ACR Convergence 2024 in Washington, D.C. The oral presentation will take place on November 19, 2024.
LEVI-04 is a proprietary p75 neurotrophin receptor fusion protein (p75NTR-Fc) designed to provide analgesia by inhibiting NT-3 activity and restoring neurotrophin homeostasis. The drug supplements the endogenous p75NTR binding protein to scavenge excess neurotrophins present in osteoarthritis.

Phase II Trial Details

The data comes from a multiple-arm, multicenter, randomized, double-blind, placebo-controlled Phase II study (NCT05618782) that enrolled 518 participants with pain and disability due to osteoarthritis of the knee.
Professor Philip Conaghan MD, Director NIHR Leeds Biomedical Research Centre and Principal Investigator, stated, “We look forward to presenting more details of what were truly exceptional results from this robust and well-designed study. Safe and effective pain management is of critical importance in osteoarthritis with existing treatments limited by adverse effects, addiction liabilities and poor efficacy and we believe LEVI-04 has the potential to offer a vital new treatment option to millions of patients in need.”

Presentation Information

  • Title: LEVI-04, a novel neurotrophin-3 inhibitor, substantially improves pain and function without deleterious effects on joint structure 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.
  • Abstract Number: L15
  • Date and Time: Tuesday, 19 November, 2024, 08:00 EST

About LEVI-04

LEVI-04 represents a novel approach to treating osteoarthritis and chronic pain by targeting NT-3, a member of the neurotrophin family. Levicept estimates the market opportunity for osteoarthritis drugs to be in excess of $10 billion.
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Reference News

[1]
Levicept to Present Phase II Data at ACR Convergence 2024 - Morningstar
morningstar.com · Oct 28, 2024

Levicept Ltd to present Phase II trial results of LEVI-04, a novel osteoarthritis treatment, at ACR Convergence 2024 in ...

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