Immunotherapy approaches to tackling osteoarthritis
Osteoarthritis, a debilitating joint disease that affects over 250 million people globally, is a major cause of disability that puts a huge strain on patients and healthcare systems. The condition occurs when the protective cartilage that cushions the ends of bones gradually wears away, resulting in joint pain, stiffness and reduced mobility. At present, treatment mainly consists of relieving pain and improving joint function through lifestyle changes, physical therapy and medication. “Pain killers can only be taken over a limited duration,” notes Anti-IL-6 project coordinator René Azoulai, CEO of Peptinov(opens in new window) in France. In severe cases, surgical procedures are required.
Treatment based on immunotherapy
Peptinov is seeking to bring to market a novel treatment for osteoarthritis based on immunotherapy. The aim is to halt inflammation-driven destruction of the cartilage in the joints, by neutralising the excess of a key pro-inflammatory protein known as IL-6. The company’s vaccine-like drug works by stimulating the patient’s own immune system to produce antibodies that neutralise the IL-6 overproduced. By doing so, disease progression can be halted. An initial Phase I clinical trial yielded encouraging safety, tolerability and preliminary efficacy data on 24 patients. The aim of the Anti-IL-6 project, supported by the European Innovation Council(opens in new window), is to conduct a Phase II clinical trial to bring the therapy closer to clinical readiness. “The multifactorial nature of osteoarthritis means that careful patient selection is critical for experimental treatments to be successful,” adds Azoulai. “In our case, we selected patients with inflammation in the knee.”
Trials on patients with knee osteoarthritis
The trial involves 204 patients with knee osteoarthritis and inflammation across five European countries (Czechia, Denmark, France, Poland and Romania). Each participant will receive, over a two-year period, multiple doses, typically one every five months, of either the experimental treatment or a placebo. The main project goal is to demonstrate significant benefits in terms of pain reduction and joint function after one year, for patients receiving the experimental treatment in comparison to patients receiving a placebo. Another key goal is to demonstrate a reduced disease progression after two years, i.e. a decreased reduction in cartilage thickness in the knees of patients receiving the experimental treatment compared to patients receiving a placebo. Participants will visit clinical centres throughout the duration of the trial in order to receive their treatment, and to have regular medical assessments. Patient progress is also assessed by an osteoarthritis assessment questionnaire (WOMAC), which seeks to measures pain, stiffness and physical functioning.
Moving towards commercialisation
“There are no results yet, as all assessments will be conducted only once the trial has been completed,” explains Azoulai. “This means that as long as the trial is ongoing, neither the trial participants, nor the medical staff involved, know who received the experimental treatment and who received a placebo.” If the results of the Phase II trial are positive, the next step will be to perform one or several Phase III clinical trials. This is critical to gaining marketing authorisation to commercialise the treatment. “Our hope is that the hundreds of millions of people suffering from osteoarthritis in their knees and hips will ultimately benefit as a result of the project,” says Azoulai.
