4Moving Biotech Announces Positive Results From Its Phase I 4P004 Clinical Trial of Intra-articular Liraglutide Lasare for Patients With Knee Osteoarthritis

• Lasare Phase I Clinical Trial Demonstrated Acceptable Safety and Tolerability Profiles of Intra-articular Liraglutide 4P004 for the Treatment of Knee Osteoarthritis

• 4Moving Biotech has received constructive pre-IND guidance from the U.S. Food and Drug Administration (FDA) to advance its clinical development strategy with the possibility of accelerated approval.

LILLE, France & PARIS, June 10, 2024–(BUSINESS WIRE)–4Moving Biotech, a spin-off of 4P-Pharma engaged in the development of first-in-class treatments to modify the natural history of knee osteoarthritis, announces successful completion of phase trial 1 Lasare in osteoarthritis of the knee. (OA) using 4P004.

The Lasare phase I trial is a multicenter, randomized, double-blind, placebo-controlled trial involving 34 patients across three sites in Belgium.

The study evaluated the safety, tolerability, and pharmacokinetics of escalating doses of a single intra-articular injection of liraglutide (4P004).

The trial met its primary objective, confirming that intra-articular liraglutide (4P004) was safe and well tolerated. An active pharmacological dose was identified, with similar expected adverse events (EAEs) in the 4P004 groups compared to the placebo group. Pharmacokinetics, both observed and simulated Cmax values, also indicated lower systemic exposure than reported for subcutaneous liraglutide injection of the approved product, Victoza®, confirming the Company’s plan to pursue a pathway regulatory 505(b)(2) in the United States for 4P004.

Prof. François Berenbaum, Co-founder and medical director of 4Moving Biotech, said: “The success of the Phase 1 study of 4P004 underlines the quality of our progress in the search for therapeutic solutions for patients suffering from knee osteoarthritis. Additionally, with the safety and tolerability profiles established, we are confidently progressing to the next stage of clinical development with 4P004.”

As for the ultimate goal, 4Moving Biotech’s strategy aims to obtain accelerated approvals in the US and EU for rapid market entry upon completion of the Phase 2b efficacy and safety trial. foreseen. To achieve this goal, the Company recently received constructive pre-IND guidance from the FDA, translating 4Moving Biotech’s potential planned accelerated approval strategy into a highly differentiated clinical program catalyzed by a unique combination of reasonably likely surrogate endpoints. , supported by sophisticated in silico AI. based prognostic modeling.

Revitalization of Rattenbach, President of 4Moving Biotechsaid: “Beyond the positive results of our phase I clinical study in knee osteoarthritis, the positive feedback from the FDA has given tremendous momentum to our accelerated go-to-market strategy, in the hope to provide osteoarthritis patients with the first treatment capable of modifying the natural course of the disease. »

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About 4Moving Biotech
Incorporated in mid-2020 as a spin-off from 4P-Pharma, 4Moving Biotech is a clinical-stage biotechnology company dedicated to the development of the disease-modifying drug for osteoarthritis (DMOAD). Its mission is to provide a lasting therapeutic solution to the significant and unmet medical need of osteoarthritis. The company is headquartered at the Institut Pasteur in Lille, France.
Website: https://www.4movingbiotech.com/
LinkedIn: https://fr.linkedin.com/company/4moving-biotech

About Lasare
This project received funding from the Eurostars-2 joint program with co-financing from the European Union’s Horizon 2020 research and innovation program. The funding agencies supporting this work are (in alphabetical order of participating countries): France: BPI France; Germany: Project Management Agency (DLR), which acts on behalf of the Federal Ministry of Education and Research (BMBF); Netherlands: Netherlands Business Agency (RVO); Switzerland: Innosuisse (the Swiss Innovation Agency).

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View source version on businesswire.com: https://www.businesswire.com/news/home/20240609275171/en/

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