Lille & Paris, June 10th, 2024 - 4Moving Biotech, a spin-off of 4P-Pharma committed to developing first-in-class treatments to modify the natural course of knee osteoarthritis announces the successful achievement of the Phase 1 Lasare trial in knee osteoarthritis (OA) patients using 4P004.
Lasare Phase I trial is a multi-center, randomized, double-blinded, placebo-controlled involving 34 patients across three sites in Belgium.
The study evaluated the safety, tolerability, and pharmacokinetics of ascending doses of a single intra-articular injection of liraglutide (4P004). The trial reached its primary objective, confirming that intra-articular liraglutide (4P004) was safe and well tolerated. A pharmacological active dose has been identified, with similar expected adverse events (EAEs) in the 4P004 groups as the placebo group. Pharmacokinetics, both observed and simulated Cmax values, also indicated lower systemic exposure than reported for subcutaneous liraglutide injection from the approved product, Victoza®, affirming the company’s plan to pursue a 505(b)(2) regulatory pathway in the US for 4P004.
Pr. Francis Berenbaum, Co-founder and Chief Medical Officer of 4Moving Biotech, declared: "The Success of the Phase 1 study of 4P004 underscores the quality of our advancements in the quest for therapeutic solutions for patients suffering from knee osteoarthritis. Furthermore, with the established safety and tolerability profiles, we are progressing confidently to the next stage of clinical development with 4P004."
As for ultimate goal, 4Moving Biotech’s strategy intends to secure accelerated approvals in the US and EU for early market entry at the end of the planned Phase 2b efficacy and safety trial. Toward this goal, the company recently received constructive pre-IND guidance from the FDA, translating 4Moving Biotech’s planned potential accelerated approval driven 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 modelling.
Revital Rattenbach, Chairwoman of 4Moving Biotech, stated: "Beyond the positive results from our phase I clinical study on knee osteoarthritis, the FDA's positive echoing has built a tremendous momentum for our accelerated strategy to the market, with hopes to bring to OA patients the first therapy being able to modify the natural course of the disease".
