4Moving Biotech (4MB), a clinical-stage biotechnology company spun off from 4P-Pharma, has enrolled the first patient in its Phase 2a clinical trial INFLAM MOTION, marking a significant milestone in the development of 4P004, a potential first-in-class intra-articular GLP-1 analog for knee osteoarthritis treatment.
The multicenter, randomized, double-blind, placebo-controlled Phase 2a trial will evaluate 4P004 in 129 patients diagnosed with knee osteoarthritis across Europe, the United States, and Canada. This represents the first human efficacy evaluation of the investigational therapy, which targets GLP-1-mediated pathways to address pain, inflammation, and tissue damage directly within the joint.
Novel Therapeutic Approach
"Enrolling our first patient is a pivotal step toward rewriting the treatment paradigm for knee osteoarthritis," said Professor Francis Berenbaum, MD, PhD, Chief Medical Officer at 4Moving Biotech. "Almost 600 million people live with OA, yet no disease-modifying therapy has been done to patients. By acting directly in the joint, 4P004 tackles pain, inflammation, and tissue damage through GLP-1-mediated pathways."
The targeted intra-articular delivery approach aims to unlock the full therapeutic potential of GLP-1 biology for osteoarthritis treatment, representing a departure from current symptomatic therapies toward potential disease modification.
Trial Design and Endpoints
The INFLAM MOTION study's primary endpoint focuses on the reduction in knee pain at weeks 4 and 12. Key secondary objectives include assessing synovial changes through contrast-enhanced MRI and conducting exploratory analyses of blood and imaging biomarkers as potential surrogates for long-term disease progression and delay to total knee replacement.
The study timeline spans 12 months, with patient enrollment occurring over 9 months and follow-up completion scheduled before topline results in the second half of 2026. The trial has been specifically designed to generate the first human evidence that 4P004 can deliver both clinical relief and measurable structural benefit.
Development Strategy
Insights from this Phase 2a readout will inform the design of the forthcoming Phase 2b program, whose primary aim will be to confirm surrogate endpoints that reliably predict the hard endpoint of delaying time to total knee replacement. This progression represents a strategic approach to developing what the company terms a Disease-Modifying Osteoarthritis Drug (DMOAD).
4Moving Biotech was incorporated in mid-2020 as a spin-off of 4P-Pharma and is headquartered at the Pasteur Institute in Lille, France. The company's mission centers on providing sustainable therapeutic solutions to address the significant unmet medical need in osteoarthritis treatment, where current options remain limited to symptomatic management rather than disease modification.
