After recently completing the recruitment for its Phase I trial, 4Moving Biotech is already laying out plans for the upcoming Phase IIb trial investigating 4P004 (liraglutide) in knee osteoarthritis.
The France-based biotech plans to initiate the next trial at the end of next year, executive chairwoman Revital Rattenbach, PhD, told Clinical Trials Arena.
To establish itself in the osteoarthritis space, 4Moving Biotech is seeking to include innovative endpoints in the study. Rattenbach explained that approved symptomatic drugs used classical endpoints such as pain reduction at 12 weeks. However, patients with osteoarthritis suffer from both acute and chronic pain and it is difficult to show efficacy at 12 months in the latter pain state due to high levels of the placebo effect, she noted.
As such, the biotech wants to demonstrate efficacy not only in pain but also in the function and structure of the joint in 12 months. These endpoints will be measured all along the trial, and not at very precise moments, Rattenbach said.
Also, 4Moving Biotech is collaborating with an AI company to simulate an in-silico clinical trial to predict what will happen after the 12-month endpoint. The company plans to run the Phase IIb in vivo trial in conjunction with the in-silico trial with the same kind of patients.
The upcoming study is likely to recruit 350 patients who have established chronic disease. 4P004 is anti-inflammatory, anti-catabolic and anabolic, so there is no age limit, and the trial will recruit patients with a broad range of ages, Rattenbach added.
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The trial will open international sites in the US and Europe. Rattenbach said that the biotech will definitely open sites in France, with other countries yet to be decided.
4P004 is a GLP-1 analogue, which targets all the cells of the joint. The drug is not only targeting the structure but also has symptomatic effects. Rattenbach explained that when the structure of the joint is degraded, it induces inflammation, which will degrade the structure more.
Rattenbach adds: “We have a drug in our hands that will stop the vicious cycle that is observed in osteoarthritis.”
Ongoing Phase I trial with 4P004
4Moving Biotech is currently conducting a Phase I trial (NCT05419856) investigating the intra-articular injection. The trial is expected to wrap up at the end of January with final data to be reported in March 2024.
The study has randomised 34 patients with Grade 2 to 4 osteoarthritis on the Kellgren and Lawrence severity index (KL 2-4). The study is being conducted in three sites in Belgium.