Levicept presents new data from Phase II Trial of LEVI-04, a novel non-opioid investigational treatment for osteoarthritis
Levicept Ltd, a clinical-stage biotechnology company focused on the development of LEVI-04, a potential first-in-class treatment for osteoarthritis (OA), today presented new data from its 518-patient Phase II trial of LEVI-04 (ClinicalTrials.gov ID: NCT05618782) at the American College of Rheumatology's annual meeting, ACR Convergence 2026, being held from 6 to 11 November in Orlando, Florida.
Results from the Phase II trial have previously been published in The Lancet and demonstrated significant symptom control. LEVI-04 was well tolerated in this study. Levicept has also presented analysis suggesting LEVI-04 may have the potential to modify the disease progression of OA2. To Levicept’s knowledge, this is the first time a molecule has demonstrated analgesia and potential disease modification in a clinical study in OA, and if approved, LEVI-04 would be the first new systemic treatment for OA in over two decades.
The new data presented at ACR Convergence were from an ex vivo study examining the effects of LEVI-04 in plasma samples taken from the Phase II trial participants on neurotrophin (NT) activity. The primary pharmacology of LEVI-04 is neurotrophin-3 (NT-3) inhibition. It is a potent binder of NT-3 and interacts weakly and reversibly with nerve growth factor (NGF). Plasma samples from LEVI-04-treated trial participants reduced NT-3-induced activity but did not inhibit NGF-induced activity in an ex vivo assay.
Simon Westbrook, Founder and CSO of Levicept said, “These data demonstrate that LEVI-04 successfully inhibited NT-3 activity in people with OA while permitting key NGF signalling. In this way, LEVI-04 supports a return to neurotrophin homeostasis and preserves physiological NGF signalling for joint health maintenance. This finding is in line with our previous work in which LEVI-04 showed reduction of OA pain and was associated with reduced bone marrow lesions2.”
Levicept also presented additional post-hoc analysis of Patient Acceptable Symptom State (PASS) which is designed of a measure of patients ‘feeling well’. LEVI-04, especially at higher doses, was consistently associated with a high proportion of the participant population achieving both PASS and a low strict symptom state for both pain and function, as well as a shorter time to response compared to placebo.
Presentation details:
LEVI-04 (p75NTR-Fc) Provides Analgesia via Neurotrophin Homeostasis, Selectively Inhibiting NT-3 While Sparing NGF Activity: Ex vivo data from a RCT
Poster presentation (2051) – Tuesday, 10 November, 10:30AM – 12:30PM
Simon Westbrook, Claire Herholdt, Iwona Bombelka and Philip Conaghan
LEVI-04, a novel neurotrophin-modulator for treating knee OA, results in higher proportions achieving patient acceptable symptom states for both pain and physical function
Poster presentation (0256) – Tuesday, 10 November, 10:30AM – 12:30PM
Asger R. Bihlet, Gasper Letnar, Simon Westbrook, Claire Herholdt, Iwona Bombelka, Bernadette Hughes, Michael C Perkins and Philip Conaghan