4Moving Biotech (4MB), a clinical-stage biotech developing next-generation therapies for osteoarthritis (OA), has announced that the US FDA has cleared its groundbreaking osteoarthritis therapy.
The nod to Investigational New Drug (IND) application for 4P004 paves the way for the Phase 2a INFLAM MOTION trial to expand into the United States.
The FDA approval marks a major milestone in 4MB’s global clinical rollout, which already spans Europe and Canada, and reinforces the company’s position at the forefront of the race to deliver the first disease-modifying osteoarthritis drug (DMOAD) to patients worldwide.
Preclinical studies show that 4P004 modulates multiple biological markers across the joint, potentially slowing structural damage while improving function.
“FDA’s clearance of our IND represents a major validation of our program and enables the full execution of our clinical strategy across Europe, Canada, and the United States,” said Luc Boblet, CEO of 4Moving Biotech.
“This milestone strengthens our position as one of the most advanced DMOAD developers globally and brings us closer to demonstrating the transformative potential of 4P004 for the millions of patients worldwide who currently have no disease-modifying options.”
The INFLAM MOTION trial is a three-month, multicenter, randomized, double-blind, placebo-controlled Phase 2a study targeting 129 patients with knee osteoarthritis and synovitis.
This integrated approach—combining clinical, imaging, and biomarker data—is designed to support future regulatory discussions on accelerated or conditional approval, positioning 4P004 at the cutting edge of OA drug development.
“4P004, a GLP-1 receptor agonist administered intra-articularly, allows specific targeting of the diseased joint and joint tissues, aiming to relieve pain while also addressing the underlying disease process, thus offering an exciting novel approach for patients living with painful knee osteoarthritis,” said Thomas J. Schnitzer, Professor of Medicine, Northwestern University.
“As the U.S. Coordinating Investigator, I am pleased to support the INFLAM MOTION study and look forward to evaluating this promising therapeutic approach for patients with knee osteoarthritis.”
Professor Francis Berenbaum, Chief Medical Officer of 4Moving Biotech, added: “The regulatory progress across three major regions underscores the scientific robustness of 4P004.
"INFLAM MOTION is designed to deliver clinically meaningful pain improvement while generating high-resolution structural and biological data to guide the next stage of development. We believe 4P004 has the potential to redefine how osteoarthritis is treated.”
