Health Canada Approves 4Moving Biotech’s Phase 2a Trial for Knee Osteoarthritis
4Moving Biotech (4MB), a pioneering biotechnology company and a spin-off of 4P-Pharma, has received authorization from Health Canada to initiate its Phase 2a INFLAM MOTION clinical trial. This study aims to evaluate the efficacy of 4P004, a first-in-class disease-modifying treatment (DMOAD) designed to alter the natural progression of knee osteoarthritis (OA).
INFLAM MOTION: A Milestone in Osteoarthritis Treatment Research
The INFLAM MOTION trial is a Phase 2a multicenter, randomized, double-blind, placebo-controlled study that will be conducted across multiple sites in the European Union, the United States, and Canada. Specifically, Canada will host three clinical trial sites as part of this groundbreaking research effort. The study will enroll 129 patients diagnosed with knee osteoarthritis, marking a significant step in assessing the real-world therapeutic potential of 4P004.
4P004 is a GLP-1 (glucagon-like peptide-1) analog developed for intra-articular administration. Unlike existing treatments that primarily focus on symptom relief, 4P004 is engineered to target the underlying disease mechanisms by leveraging the analgesic, anti-inflammatory, anti-catabolic, and anabolic properties of GLP-1. Preclinical studies have demonstrated promising results, suggesting that 4P004 may not only alleviate pain but also slow disease progression and enhance joint function by modulating key biological pathways throughout joint tissues. This innovative mechanism differentiates 4P004 from conventional treatments and positions it as a potential breakthrough in osteoarthritis management.
Health Canada Authorization and Its Significance
Luc Boblet, CEO of 4Moving Biotech, emphasized the importance of Health Canada’s authorization, stating, “This regulatory approval is a pivotal milestone for 4Moving Biotech, reinforcing our commitment to advancing disease-modifying therapies in osteoarthritis. The INFLAM MOTION study represents an exciting opportunity to demonstrate the true potential of 4P004 as the first therapy capable of modifying the disease course rather than just alleviating symptoms.”
The primary goal of the INFLAM MOTION trial is to evaluate the effectiveness of a single intra-articular injection of 4P004 in reducing knee pain, with assessments conducted at week 4 and continuing up to week 12. Additionally, the study aims to assess changes in knee structure through contrast-enhanced MRI imaging, a cutting-edge technique that enables precise visualization of joint tissue alterations. Another crucial objective of the trial is to identify new surrogate biomarkers that could serve as indicators of disease progression, ultimately helping to predict the need for total knee replacement.
The Need for Disease-Modifying Osteoarthritis Treatments
Osteoarthritis is the most common form of arthritis, affecting over 300 million people worldwide. It is a progressive degenerative joint disease characterized by the breakdown of cartilage, inflammation, and joint pain, leading to reduced mobility and diminished quality of life. Current treatment options primarily focus on pain management and symptom relief through nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, Health and physical therapy. Health In more severe cases, surgical interventions such as total knee replacement become necessary. However, there is currently no approved disease-modifying treatment that can slow or halt the progression of OA.
By targeting the underlying mechanisms that contribute to joint degradation,Health 4P004 has the potential to fill this critical gap in OA treatment. If successful, it could revolutionize how osteoarthritis is managed by providing patients with a therapeutic option that goes beyond temporary pain Health relief.
A Strong Foundation in Clinical Research
The Phase 2a INFLAM MOTION study follows the successful completion of the LASARE Phase 1 clinical trial, which demonstrated the safety and tolerability of 4P004 in human subjects. Building on this foundation, the upcoming trial will provide further insights into the therapeutic potential of the drug and its ability to redefine treatment standards for knee osteoarthritis.
Francis Berenbaum, Chief Medical Officer of 4Moving Biotech, highlighted the significance of this next phase: “The LASARE Phase 1 trial confirmed that 4P004 has a strong safety and tolerability profile. With the INFLAM MOTION Phase 2a study, we aim to take a crucial step forward in proving its therapeutic benefits. The authorization from Health Canada is a major milestone that allows us to move ahead with confidence, ensuring that patients have access to innovative treatment options in the near future.”
Study Initiation and Next Steps
With regulatory approval secured, 4Moving Biotech is preparing to initiate the trial in Canada, with the first patient enrollment expected in the second quarter of 2025. The company is working closely with clinical investigators, research institutions, and regulatory bodies to ensure a smooth and efficient study launch.
As the INFLAM MOTION trial progresses, 4Moving Biotech remains committed to advancing innovative therapies that address the unmet needs of osteoarthritis patients. The company will continue to provide updates on the study’s progress and the potential impact of 4P004 on the future of osteoarthritis treatment.
For more information about 4Moving Biotech, the INFLAM MOTION study, and ongoing research efforts, please visit www.4movingbiotech.com.
About 4Moving Biotech
Incorporated in mid-2020 as a spin-off of 4P-Pharma, 4Moving Biotech is a clinical-stage biotechnology company dedicated to the development of the Disease-Modifying Osteoarthritis Drug (DMOAD). Its mission is to provide a sustainable therapeutic solution to the significant unmet medical need of osteoarthritis. The company is headquartered at the Pasteur Institute in Lille, France
