Health Canada has authorized 4Moving Biotech (4MB) to launch the Phase 2a INFLAM MOTION clinical trial for its flagship program 4P004, a potential first-in-class treatment for knee osteoarthritis. This multicenter, randomized, double-blind, placebo-controlled study marks a significant step toward developing what could become the first disease-modifying osteoarthritis drug (DMOAD).
The trial will enroll 129 patients across sites in the European Union, United States, and Canada, with patient enrollment expected to begin in the second quarter of 2025. This proof-of-concept study aims to evaluate the efficacy of 4P004 in individuals suffering from knee osteoarthritis, a condition with significant unmet medical needs.
Novel Mechanism of Action
4P004 represents an innovative approach to osteoarthritis treatment as a GLP-1 analog specifically tailored for intra-articular administration in the knee joint. The drug was developed to harness the analgesic, anti-inflammatory, anti-catabolic, and anabolic benefits of GLP-1 receptors.
Preclinical studies suggest that 4P004 may slow disease progression and improve joint function by modulating biological pathways throughout all joint tissues. This comprehensive approach differentiates it from current symptomatic treatments that primarily address pain without modifying the underlying disease process.
Study Design and Objectives
The INFLAM MOTION trial's primary objective is to assess the efficacy of a single intra-articular injection of 4P004 in reducing knee pain by week 4 and maintaining this effect through week 12.
Secondary objectives include:
- Evaluating knee structure changes using contrast-enhancement MRI
- Investigating new surrogate biomarkers for disease progression
- Assessing potential delay to total knee replacement
This follows the successful completion of the LASARE Phase 1 clinical trial, which demonstrated a favorable safety and tolerability profile for 4P004.
Executive Perspectives
Luc Boblet, CEO of 4Moving Biotech, emphasized the significance of this regulatory milestone: "This authorization from Health Canada is a major milestone in the 4MB value creation path. Advancing the INFLAM MOTION study is an exciting step towards demonstrating the potential of 4P004 as the first disease-modifying osteoarthritis drug."
Francis Berenbaum, Chief Medical Officer of 4MB, added: "Following a strong demonstration of the safety and tolerability profile of 4P004 in the LASARE Phase 1 clinical trial, we aim to establish therapeutic potential and redefine treatment standards for knee osteoarthritis with the INFLAM MOTION Phase 2a study."
Addressing a Significant Unmet Need
Knee osteoarthritis represents one of the most common joint disorders worldwide, causing pain, stiffness, and reduced mobility for millions of patients. Current treatment options are largely limited to pain management, with advanced cases often requiring total knee replacement surgery.
A successful disease-modifying treatment could potentially transform the management of osteoarthritis by addressing the underlying pathology rather than merely treating symptoms. This approach could significantly improve patient outcomes and quality of life while potentially reducing the need for invasive surgical interventions.
About 4Moving Biotech
4Moving Biotech was established in mid-2020 as a spin-off of 4P-Pharma. The clinical-stage biotechnology company is dedicated to developing disease-modifying treatments for osteoarthritis, with a mission to provide sustainable therapeutic solutions for this significant unmet medical need. The company is headquartered at the Pasteur Institute in Lille, France.
With the Health Canada authorization secured, 4Moving Biotech is positioned to advance its innovative treatment approach through clinical development, potentially offering new hope to the millions of patients suffering from knee osteoarthritis worldwide.
