4Moving Biotech has completed patient enrolment in its Phase IIa INFLAM MOTION trial of 4P004, an intra-articular glucagon-like peptide-1 (GLP-1) receptor agonist, for knee osteoarthritis linked to synovitis.
The proof-of-concept, multi-centre, double-blind, placebo-controlled study includes patients from Europe, the US, and Canada, focusing on an inflammatory phenotype linked to increased structural progression in knee osteoarthritis.
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It randomised a total of 129 patients and is designed to evaluate both symptomatic and objective biological responses.
All patients have symptomatic knee osteoarthritis with synovitis confirmed by contrast-enhanced magnetic resonance imaging (MRI) and are randomised to receive a single injection of 4P004 (2mg) or placebo, followed by a three-month assessment period.
Selection criteria for the trial emphasise synovitis as a risk factor for progression rather than obesity status.
The primary endpoint is the reduction in knee pain at week 4.
Secondary endpoints include changes in synovial tissue thickness, overall synovitis burden measured by MRI, knee pain at week 12, and analysis of imaging and circulating biomarkers associated with osteoarthritis progression.
4Moving Biotech chief medical officer professor Francis Berenbaum said: “Completion of enrolment represents an important milestone not only for the development of 4P004 but also for the broader understanding of inflammatory knee osteoarthritis.
“Increasing evidence indicates that synovial inflammation is a major driver of pain and identifies a phenotype associated with structural progression and a greater likelihood of future knee replacement.
“By acting directly within the joint, 4P004 has been designed not simply to provide symptomatic relief, but to selectively modulate this progression-associated inflammatory pathway, while minimising systemic exposure.”
Patient follow-up is ongoing. Top line data from the study are anticipated by the end of December 2026.
These results are intended to inform the design of a potential Phase IIb clinical trial and support future development plans for 4P004.
