4Moving Biotech reports successful Phase I 4P004 trial of intraarticular Liraglutide for knee osteoarthritis

4Moving Biotech, a division of 4P-Pharma focused on innovative treatments for knee osteoarthritis, has announced the successful completion of its Phase 1 Lasare clinical trial. This trial assessed the safety and tolerability of 4P004, a novel intra-articular formulation of liraglutide, in patients with knee osteoarthritis.

The Lasare Phase I trial was a multi-center, randomized, double-blind, placebo-controlled study involving 34 participants across three sites in Belgium. The trial investigated the safety, tolerability, and pharmacokinetics of different doses of a single intra-articular injection of liraglutide (4P004). The primary objective was achieved, demonstrating that 4P004 is safe and well-tolerated. The study also identified a pharmacologically active dose, with adverse events in the 4P004 group comparable to those in the placebo group. Additionally, both observed and simulated Cmax values indicated lower systemic exposure compared to the subcutaneous injection of liraglutide found in the approved product, Victoza®. This supports 4Moving Biotech's plan to pursue the 505(b)(2) regulatory pathway in the US.

Professor Francis Berenbaum, Co-founder and Chief Medical Officer of 4Moving Biotech, stated that the Phase 1 study's success highlights the quality of their advancements in seeking therapeutic solutions for knee osteoarthritis. With established safety and tolerability profiles, the company is progressing confidently towards the next clinical development phase for 4P004.

4Moving Biotech aims to secure accelerated approvals in the US and EU to ensure early market entry following the planned Phase 2b efficacy and safety trial. The company recently received constructive pre-IND guidance from the FDA, aligning with their strategy for potential accelerated approval through a unique clinical program supported by sophisticated AI-based prognostic modeling.

Revital Rattenbach, Chairwoman of 4Moving Biotech, emphasized that the positive results from the Phase 1 clinical study, combined with the FDA's supportive feedback, have created significant momentum for their accelerated market strategy. The goal is to offer a therapy that can potentially modify the natural progression of osteoarthritis, providing much-needed relief for patients.

4Moving Biotech was established in mid-2020 as a spin-off of 4P-Pharma and is headquartered at the Pasteur Institute in Lille, France. The company is dedicated to developing disease-modifying osteoarthritis drugs (DMOADs) to address the significant unmet medical needs in osteoarthritis treatment.

The Lasare project received funding from the Eurostars-2 joint program, with co-funding from the European Union Horizon 2020 research and innovation program. Supporting agencies include BPI France, the Project Management Agency (DLR) in Germany, the Netherlands Enterprise Agency (RVO), and Innosuisse in Switzerland.

4Moving Biotech's commitment to developing first-in-class treatments for knee osteoarthritis continues to advance, with the successful completion of the Phase 1 Lasare trial marking a significant milestone in their mission to provide a sustainable therapeutic solution for osteoarthritis patients.