4Moving Biotech completes enrollment in phase 2a INFLAM MOTION study evaluating first-in-class intra-articular GLP-1 therapy?targeting synovitis as a driver of pain and disease progression in knee osteoarthritis

4Moving Biotech (4MB), a clinical-stage biotechnology company dedicated to developing first-in-class therapies for inflammatory knee osteoarthritis, announced the completion of patient enrollment in INFLAM MOTION, its international phase 2a proof-of-concept study. The trial is evaluating the efficacy and safety of 4P004, an investigational intra-articular GLP-1 receptor agonist designed to address the?inflammatory mechanisms underlying both symptoms and disease progression in knee osteoarthritis. 

INFLAM MOTION is a multicenter, randomized, double-blind, placebo-controlled phase 2a clinical trial conducted across Europe, the United States and Canada. A total of 129?patients with symptomatic knee osteoarthritis associated with contrast enhanced-MRI-confirmed synovitis were randomized to receive a single intra-articular injection of either 4P004 (2 mg) or placebo, followed by a three-month evaluation period. The study population was selected based on the presence of synovitis rather than obesity status.?This phenotype-driven strategy is intended to focus development on patients with a biological feature associated with a higher risk of osteoarthritis progression. 

Completion of enrollment marks a major operational and strategic milestone for the programme, transitioning the study into patient follow-up and preparation for clinical data readout. 

Unlike conventional osteoarthritis studies that primarily assess symptomatic improvement, INFLAM MOTION was designed to go beyond the evaluation of pain relief by integrating contrast-enhanced magnetic resonance imaging (CE-MRI)?to assess changes in synovial tissue thickening and inflammation. The study will investigate whether modulation of synovitis is associated with clinical benefit and with?an objective biological response in a disease pathway linked to structural progression and future knee replacement. It is expected to generate one of the most comprehensive datasets to date exploring the relationship between symptoms, imaging biomarkers, and inflammatory biology following local GLP-1 receptor activation. 

“Completion of enrollment represents an important milestone not only for the development of 4P004 but also for the broader understanding of inflammatory knee osteoarthritis,” said Professor Francis Berenbaum, MD, PhD, chief medical officer of 4Moving Biotech. “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 minimizing systemic exposure.?For the first time, INFLAM MOTION will allow us to evaluate whether local GLP-1 receptor activation can translate into a coherent clinical and biological response, combining symptomatic improvement with objective imaging evidence of?reduced synovial tissue thickening and inflammation.”

The primary endpoint of the study is the reduction in knee pain at Week 4. Key secondary endpoints?include changes in synovial tissue thickness and overall synovitis burden assessed by contrast-enhanced MRI, knee pain at Week 12, imaging biomarkers, and circulating biomarkers associated with osteoarthritis progression. 

Beyond evaluating clinical efficacy, INFLAM MOTION is expected to provide important translational insights into the relationship between synovial inflammation, imaging biomarkers and patient outcomes.?By studying a synovitis-defined population, the trial is intended to determine whether targeting this inflammatory phenotype may provide a basis for an approach extending beyond symptom control. These data are intended to inform patient selection, endpoint strategy and biomarker integration for the subsequent phase 2b study, supporting the development of a differentiated regulatory package built upon both clinical benefit and objective evidence of biological activity relevant to potential disease modification. 

“Completing enrollment marks the transition from operational execution to clinical value creation,” said Luc Boblet, chief executive officer of 4Moving Biotech. “Over the coming months, INFLAM MOTION is expected to generate a robust clinical dataset assembled around local GLP-1 therapy in osteoarthritis, integrating patient-reported outcomes, advanced imaging and molecular biomarkers.?The value of this study lies in determining whether local GLP-1 therapy can combine symptom improvement with measurable modulation of synovitis, an inflammatory feature associated with disease progression.?We believe these data will not only guide the next stage of clinical development but also contribute to the growing scientific momentum supporting inflammation as a therapeutic target for altering the course of osteoarthritis, rather than solely managing its symptoms. We look forward to sharing topline results before the end of the year.”

Patient follow-up is ongoing. Topline results are expected by the end of December 2026. The results are expected to inform the design of the subsequent phase 2b clinical trial, which will further evaluate both clinical benefit and the disease-modifying potential of 4P004 in patients with the synovitis-associated inflammatory phenotype, and contribute to future regulatory interactions supporting the path forward of 4P004 toward market approval. 

Incorporated in mid-2020 as a spin-off of 4P-Pharma, 4MB is a clinical stage biotechnology company dedicated to the development of the disease-modifying osteoarthritis drug (DMOAD). Its mission is to provide a sustainable therapeutic solution to the significant unmet medical need in osteoarthritis.

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