Science

Levicept is developing LEVI-04, a fully human chimeric fusion protein that combines the Fc fragment of human immunoglobulin G1 with the p75 neurotrophin receptor (p75 NTR), for the treatment of chronic pain.

LEVI-04 is a novel, first-in-class neurotrophin-3 (NT-3) inhibitor, designed to restore neurotrophin homeostasis and thereby provide profound analgesia without use-limiting side effects including rapid progression of osteoarthritis observed with anti-NGF antibodies.

LEVI-04 provides analgesia via inhibition of NT-3 activity and returns neurotrophin homeostasis by supplementing the endogenous p75NTR binding protein to scavenge excess neurotrophins present in chronic pain states. LEVI-04 retains the important trophic effects of the neurotrophins, including joint re-modelling.

In a Phase II study of more than 510 participants with pain and disability due to osteoarthritis of the knee (ClinicalTrials.gov ID: NCT05618782), LEVI-04 met all primary and secondary endpoints showing significant analgesia across all measures. LEVI-04 was shown to be well-tolerated with no increase in rapid joint deterioration compared to placebo.

LEVI-04 is under development for the treatment of osteoarthritis and has substantial potential in other pain indications.