Health Canada Approves 4Moving Biotech’s Phase 2a Trial for Knee Osteoarthritis
4Moving Biotech (4MB), a spin-off of 4P-Pharma dedicated to developing first-in-class treatments that modify the natural history of knee osteoarthritis, has received authorization from Health Canada to initiate the Phase 2a INFLAM MOTION “Proof-of-Concept” study. This clinical trial will evaluate the efficacy of 4P004 in patients with knee osteoarthritis, marking a significant step in the development of disease-modifying osteoarthritis drugs (DMOADs).
Study Overview
The INFLAM MOTION Study is a Phase 2a multicenter, randomized, double-blind, placebo-controlled trial set to take place across the European Union (EU), the United States, and Canada. The trial will involve 129 patients, including those enrolled at three clinical sites in Canada, making it a key international study in knee osteoarthritis research.
4P004, a glucagon-like peptide-1 (GLP-1) analog formulated for intra-articular administration, is designed to leverage the analgesic, anti-inflammatory, anti-catabolic, and anabolic effects of GLP-1. Preclinical findings suggest that 4P004 may not only alleviate knee pain but also slow disease progression by modulating biological pathways across multiple joint tissues. This positions 4P004 as a potential breakthrough therapy capable of modifying the underlying disease rather than simply addressing symptoms.
CEO Perspective on Study Authorization
Luc Boblet, CEO of 4Moving Biotech, emphasized the significance of Health Canada’s approval: “This authorization from Health Canada is a major milestone in 4MB’s value creation path. Advancing the INFLAM MOTION study is an exciting step toward demonstrating the potential of 4P004 as the first disease-modifying osteoarthritis drug (DMOAD).”
Study Objectives and Expected Impact
The primary goal of the INFLAM MOTION study is to evaluate the efficacy of a single intra-articular injection of 4P004 in reducing knee pain from week 4 to week 12. The study will also assess knee structure using contrast-enhanced MRI, investigate potential biomarkers for disease progression, and evaluate how 4P004 could delay the need for total knee replacement.
Francis Berenbaum, Chief Medical Officer of 4MB, highlighted the importance of this research: “Following a strong demonstration of the safety and tolerability profile of 4P004 in the LASARE Phase 1 clinical trial, we aim to establish its therapeutic potential and redefine treatment standards for knee osteoarthritis with the INFLAM MOTION Phase 2a study. The Health Canada authorization is an important milestone that allows us to move forward with confidence and continue developing this innovative treatment option for patients.”
Scientific Rationale Behind 4P004
Current treatment options for knee osteoarthritis primarily focus on symptom relief, such as pain management with nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and in severe cases, total knee replacement surgery. However, these approaches do not address the underlying disease mechanisms.
4P004’s mechanism of action differentiates it from traditional osteoarthritis treatments by targeting inflammation and cartilage degeneration directly. As a GLP-1 analog, it is believed to exert protective effects on joint tissues, reducing inflammation and supporting tissue repair processes. This makes 4P004 a promising candidate for a truly disease-modifying osteoarthritis treatment.
Previous Clinical Findings and Future Outlook
The LASARE Phase 1 trial demonstrated a favorable safety and tolerability profile for 4P004, paving the way for its continued development in Phase 2a. If successful, the INFLAM MOTION study could provide critical data supporting the drug’s advancement into later-stage trials and eventual regulatory approval.
With patient enrollment expected to begin in the second quarter of 2025, the study marks a crucial step in bringing innovative osteoarthritis treatments to market. By combining cutting-edge science with a patient-centric approach, 4Moving Biotech aims to address a significant unmet need in knee osteoarthritis treatment and improve long-term outcomes for millions of patients worldwide.
