4Moving Biotech’s 4P004 Receives FDA IND Nod For Osteoarthritis Treatment
Clinical-stage biotech company 4Moving Biotech (4MB) has received U.S. FDA Investigational New Drug (IND) clearance for its osteoarthritis drug 4P004, allowing the company to expand its Phase 2a INFLAM MOTION trial into the United States.
The approval enables 4MB to add leading U.S. clinical sites to its ongoing study, which is already running in Europe and Canada, marking a major step in the company’s global development strategy for what it aims to be the first disease-modifying osteoarthritis drug (DMOAD).
4P004 is a first-in-class intra-articular GLP-1 receptor agonist designed to be injected directly into the knee joint. Unlike conventional pain therapies, it is intended to reduce inflammation, protect joint tissue, and slow disease progression, while also relieving pain.
Preclinical studies have shown that the drug acts across multiple tissues of the joint, including cartilage, synovium, and bone, supporting its potential to modify the underlying disease rather than just treat symptoms.
The INFLAM MOTION trial is a randomized, double-blind, placebo-controlled Phase 2a study enrolling 129 patients with knee osteoarthritis and synovitis. The trial will evaluate:
Pain reduction at Week 4 as the primary endpoint
Pain, function, and MRI-based structural changes at Week 12
Biomarkers linked to disease progression as exploratory outcomes
This combination of clinical, imaging, and biological data is designed to support discussions with regulators on accelerated or conditional approval pathways.
U.S. enrollment will begin in Q1 2026, following site activation and investigator onboarding. The American arm of the study will be led by Dr. Thomas J. Schnitzer, Professor of Medicine at Northwestern University.
4Moving Biotech highlighted that the FDA clearance strengthens its position among the most advanced companies pursuing disease-modifying therapies for osteoarthritis, a condition that affects hundreds of millions globally and currently has no approved treatments that slow or reverse joint damage.
