4Moving Biotech (4MB), a clinical-stage biotechnology company developing novel therapies for inflammatory knee osteoarthritis, has completed patient enrollment in its international Phase 2a proof-of-concept clinical trial, INFLAM MOTION. The study is evaluating the safety and efficacy of 4P004, an investigational intra-articular GLP-1 receptor agonist designed to target the inflammatory processes associated with knee osteoarthritis progression.

The multicentre, randomised, double-blind, placebo-controlled trial enrolled 129 patients across Europe, the United States and Canada. Participants with symptomatic knee osteoarthritis and MRI-confirmed synovitis were randomly assigned to receive a single intra-articular injection of either 4P004 (2 mg) or placebo, followed by a three-month evaluation period.

Unlike conventional osteoarthritis studies that primarily focus on pain relief, INFLAM MOTION is designed to assess both clinical outcomes and biological changes. The trial incorporates contrast-enhanced magnetic resonance imaging (CE-MRI) to evaluate reductions in synovial tissue thickening and inflammation, providing insights into whether targeting synovitis can influence disease progression in addition to improving symptoms.

The study specifically recruited patients with synovitis, irrespective of obesity status, reflecting a phenotype-driven approach aimed at treating individuals with a higher risk of structural joint deterioration and future knee replacement.

Professor Francis Berenbaum, Chief Medical Officer of 4Moving Biotech, said the completion of enrollment represents a significant milestone for both the development of 4P004 and the understanding of inflammatory knee osteoarthritis. He noted that increasing scientific evidence identifies synovial inflammation as a key contributor to pain and disease progression, and that 4P004 has been designed to act directly within the joint to selectively modulate these inflammatory pathways while limiting systemic exposure.

The trial's primary endpoint is the reduction of knee pain four weeks after treatment. Key secondary endpoints include changes in synovial tissue thickness and overall inflammation measured through CE-MRI, pain reduction at Week 12, as well as imaging and circulating biomarkers associated with osteoarthritis progression.

According to the company, the study is expected to generate one of the most comprehensive datasets examining the relationship between patient-reported outcomes, imaging biomarkers and inflammatory biology following local GLP-1 receptor activation. The findings are intended to support patient selection strategies, biomarker integration and endpoint design for the planned Phase 2b clinical trial.

Luc Boblet, Chief Executive Officer of 4Moving Biotech, said the completion of enrollment marks the transition from operational execution to clinical value creation. He added that the study has the potential to demonstrate whether local GLP-1 therapy can simultaneously improve symptoms and reduce inflammation associated with disease progression, supporting the broader development of disease-modifying therapies for osteoarthritis.

Patient follow-up is currently underway, with topline data expected before the end of December 2026. The results will guide the next phase of clinical development and support future regulatory interactions as the company advances 4P004 toward potential market approval.