Levicept's novel painkiller excels in mid-stage arthritis trial

Levicept made an announcement on Tuesday regarding the success of its groundbreaking non-addictive pain-relief candidate, LEVI-04, in a Phase II clinical trial. This avant-garde analgesic achieved all primary and secondary efficacy goals, showcasing notable pain reduction in patients suffering from moderate-to-severe osteoarthritis across all doses tested.

LEVI-04 is a proprietary fusion protein targeting the p75 neurotrophin receptor. It functions by inhibiting the activity of neurotrophin-3 (NT-3) and correcting the imbalance of neurotrophins in chronic pain conditions. The drug's unique mechanism provides effective pain relief while circumventing the side effects that limit the use of anti-nerve growth factor (anti-NGF) antibodies. Simon Westbrook, Levicept’s founder and chief scientific officer, emphasized that LEVI-04 retains the beneficial trophic effects of neurotrophins, such as joint remodeling.

The clinical trial enrolled 518 patients who experienced pain and disability due to knee osteoarthritis. Participants were randomly assigned to receive either 0.3 mg/kg, 1.0 mg/kg, 2.0 mg/kg of LEVI-04, or a placebo. The primary measure of effectiveness was the change in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale from the beginning of the study to week 17.

The top-line results revealed a significant decrease of over 50% in WOMAC pain scores at all three doses of LEVI-04 compared to the placebo. Additionally, LEVI-04 outperformed the placebo on several secondary efficacy measures, including the WOMAC subscales assessing joint function and stiffness, patient global assessment, and daily pain scores.

The company highlighted that LEVI-04 was well tolerated among participants, with no increase in the incidence of rapidly progressive osteoarthritis as indicated by radiological assessments. Detailed study data is planned for publication in a peer-reviewed medical journal at a future date.

The discovery of LEVI-04 is credited to Simon Westbrook during his tenure at Pfizer. Westbrook later acquired the asset when he established Levicept. The company is now under the leadership of Eliot Forster, who took on the role of CEO last year after previously serving as the chief executive officer for both F-star and Immunocore.