- Health Canada’s approval enables 4Moving Biotech to initiate the INFLAM MOTION Phase 2a clinical trial
- The INFLAM MOTION trial serves as a proof-of-concept study for 4Moving Biotech’s flagship 4P004 program
4Moving Biotech (4MB), a spin-off of 4P-Pharma dedicated to developing first-in-class treatment that modify the natural history of knee osteoarthritis, announces that it has been authorized by Health Canada to launch the Phase 2a INFLAM MOTION “Proof-of-Concept” study for 4P004 in patients with knee osteoarthritis.
The INFLAM MOTION Study is a Phase 2a multicenter, randomized, double-blind, placebo-controlled trial conducted in the EU, US, and Canada, including three sites in Canada. It will enroll 129 patients to evaluate, for the first time, the efficacy of 4P004 in individuals with knee osteoarthritis.
4P004 is a GLP-1 analog, tailored for intra-articular use in knee osteoarthritis. It was developed to exploit the analgesic, anti-inflammatory, anti-catabolic, and anabolic benefits of GLP-1. Preclinical studies suggest that 4P004 may slow disease progression and improve joint function by modulating the biological pathways throughout all joint tissues. This positions 4P004 as a potential disease-modifying treatment with the potential to significantly improve patient outcomes.
Luc Boblet, CEO of 4MB, declared: “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 (DMOAD).”
The study’s primary objective is to assess the efficacy of a single intra-articular injection of 4P004 in reducing knee pain by week 4 and up to week 12. In addition, the study aims to assess knee structure evaluation by contrast-enhancement MRI and investigate new surrogate biomarkers for disease progression and delay to total knee replacement.
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. The Health Canada authorization granted is an important milestone that allows us to move forward with confidence and continue to develop this innovative treatment option for patients.”
4MB will proceed with the study initiation in Canada, including the first patient enrolment, which is expected in the second quarter of 2025.
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