4Moving Biotech Receives FDA IND Clearance for 4P004 , Strengthening Its Position as a Leading Innovator in Disease-Modifying Osteoarthritis Therapeutics

FDA IND clearance enabling the worldwide expansion of the INFLAM MOTION Phase 2a trial, involving major U.S. sites Advancing the first clinical proof of concept in OA with a first-in-class intra-articular GLP-1 agonist A holistic clinical strategy design establishing the foundation for a future accelerated approval pathway LILLE & PARIS, France – (BUSINESS WIRE) – 4Moving Biotech (4MB), a clinicalstage biotechnology company developing next-generation, disease-modifying therapies for osteoarthritis (OA), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for 4P004, enabling the expansion of the Phase 2a INFLAM MOTION clinical trial into the United States (US). The U.S. Food and Drug Administration (FDA) approval marks another strategic step in 4MB’s global clinical deployment across Europe, Canada, and now the U.S., reinforcing the company’s role as a front-runner in the race to deliver the first disease-modifying osteoarthritis drug (DMOAD) to patients worldwide. Preclinical studies have shown that 4P004 can modulate multiple biological markers across the whole joint, supporting its potential as a first-in-class DMOAD capable of slowing structural impairment and improving joint 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 , Chief Executive Officer 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 3-month, multicenter, randomized, double-blind, placebo-controlled Phase 2a study designed to enroll 129 patients suffering from knee osteoarthritis with synovitis. The trial includes: Pain assessment at Week 4 as the primary endpoint Pain, function, and contrast-enhanced MRI structural assessment of the synovial membrane at Week 12 Exploratory surrogate biomarkers predictive of progression This unique combination of clinical, imaging, and biomarker elements forms the foundation for future interactions with regulatory agencies on accelerated or conditional approval pathways, thereby strategically positioning 4P004 within the highest-priority segment 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, 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..” Thomas J. Schnitzer, MD, PhD , Professor of Medicine, Northwestern University Professor Francis Berenbaum, MD, PhD , Chief Medical Officer of 4Moving Biotech , concluded: “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.” 4Moving Biotech will initiate patient enrollment in the United States in Q1 2026, following site activation and investigator onboarding.

The release as fetched from its publisher. 4movingbiotech.com ↗