LILLE, France & PARIS — 4Moving Biotech said the U.S. Food and Drug Administration has granted Fast Track designation to its investigational therapy 4P004 for the treatment of knee osteoarthritis, a move aimed at accelerating development for patients with limited treatment options.
The designation applies to patients with knee osteoarthritis and synovitis who have not responded to at least two prior drug therapies. Fast Track status is intended to facilitate closer communication with regulators and support a more efficient path toward potential approval.
The company said the decision underscores both the severity of knee osteoarthritis and the lack of treatments that address the underlying progression of the disease.
4P004 is a GLP-1 analog designed for direct injection into the knee joint. The therapy is intended to deliver multiple effects, including reducing inflammation and pain while also targeting structural damage within the joint. The company is positioning the drug as a potential first-in-class disease-modifying treatment, rather than one that only provides temporary symptom relief.
“Fast Track Designation represents a meaningful regulatory milestone for the 4P004 program,” said Luc Boblet, CEO of 4Moving Biotech. “It reflects the significant unmet medical need in knee osteoarthritis and provides a structured framework for enhanced dialogue with the FDA as we prepare the next stages of development. Importantly, it will allow us to align on regular basis with the Agency on the most appropriate development pathway following Phase 2a, including the exploration of innovative approaches to accelerate patient access.”
The Fast Track designation is expected to enable more frequent interactions with the FDA, helping guide decisions on trial design, endpoints, and the overall regulatory strategy as the program advances.
The company is currently conducting the INFLAM MOTION Phase 2a trial across Europe and North America, which is designed to generate data to support future development and regulatory discussions. Topline results from that study are expected in early 2027.
“Current pharmacological treatments for knee osteoarthritis provide limited and often transient relief,” said Prof. Francis Berenbaum, Chief Medical Officer of 4Moving Biotech. “4P004 has been designed to address both symptoms and underlying disease mechanisms in patients with limited therapeutic options. The Fast Track Designation strengthens our ability to generate the evidence needed to support future regulatory decision-making and ultimately patient drug access.”
Company officials said the designation may also open the door to potential early access programs for patients once sufficient clinical data become available.
