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4Moving Biotech Announces Successful Phase I Clinical Trial of Liraglutide for Knee Osteoarthritis Treatment

Monday, June 10, 2024

4Moving Biotech, a subsidiary of 4P-Pharma, has achieved a significant milestone in its quest to develop innovative treatments for knee osteoarthritis. The successful completion of the Lasare Phase I clinical trial marks a pivotal moment for the company.

Conducted across three sites in Belgium, the multicenter, randomized, double-blind, placebo-controlled study involved 34 patients. It focused on assessing the safety, tolerability, and pharmacokinetics of escalating doses of a single intra-articular injection of liraglutide (4P004). The trial successfully met its primary objective, confirming the safety and tolerability of intra-articular liraglutide (4P004).

Moreover, the trial identified the effective pharmacological dose, with minor adverse events occurring at similar rates in both the treatment and placebo groups. Notably, observed and simulated Cmax values demonstrated lower systemic exposure post-injection compared to subcutaneous administration of Victoza® (liraglutide marketed for type 1 diabetes treatment), supporting the company's regulatory strategy to pursue the 505(b)(2) pathway in the United States for 4P004.

4Moving Biotech, emphasized the significance of the phase I study's success, highlighting the company's commitment to advancing therapeutic solutions for osteoarthritis patients. With established safety and tolerability profiles, the company is poised to progress confidently to the next stage of clinical development for 4P004.

On a strategic level, 4Moving Biotech aims to expedite the development of 4P004 towards accelerated approvals in both the United States and the European Union. Following the phase 2b trial, which will evaluate effectiveness and confirm safety, the company seeks to secure early market access. Encouragingly, recent feedback from a pre-IND meeting with the Food and Drug Administration (FDA) has provided valuable guidance, endorsing the company's clinical strategy and pursuit of accelerated approval.

4Moving Biotech, expressed optimism about the company's trajectory. Beyond the Phase I trial's positive outcomes, the FDA's supportive response has energized the company's efforts to bring a transformative treatment to osteoarthritis patients, potentially altering the disease's natural course.



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