Osteoarthritis (OA) is a major healthcare issue and is one of five leading causes of chronic disability worldwide. It affects about 15% of people aged 60 years worldwide (more than 300 million people worldwide) and up to 80% in people over age 65 in high-income countries. OA has a significant, detrimental impact on affected individuals and on national economies in terms of high healthcare costs and GDP losses due to work absenteeism. OA currently has no cure and the medical need is very high: treatments offer only pain relief, which allows temporary functionality, but masks progression of joint damage.
Peptinov has devised a promising innovative treatment against osteoarthritis: an active immunotherapy targeting interleukin-6 (IL-6), a major inflammation protein. It leverages the patient’s own immune system to target the main disease driver; inflammation. Comparable to a vaccine, the treatment stimulates generation of antibodies which neutralise a specific target – in our case the excess of IL-6 involved in inflammatory processes. IL-6 is a validated therapeutic target and our treatment could become the first disease-modifying treatment for OA, as it has the potential to halt and even reverse the disease, instead of merely suppress its symptoms. The curative aspect of our therapy constitutes a unique and strong competitive advantage compared to existing treatments, which only focus on symptoms. To the best of our knowledge, Peptinov is the only company using active immunization (stimulation of endogenous antibodies) to prevent disease progression in OA. Our anti-IL-6 therapy will be able to address OA at earlier disease stages than other strategies, which will significantly increase successful clinical outcomes due to stopping disease progression early on.
Peptinov has successfully performed a phase 1 clinical trial evaluating its anti-IL-6 immunotherapy in Knee OA (KOA) patients. The trial results show that the product has a very good safety profile and that anti-IL-6 antibodies were detected in >95% of treated patients. Encouraging trends in OA scores evaluating pain, function, quality of life, etc. were also observed.
Following these encouraging results, the Anti-IL-6 project aims at demonstrating a clinical proof of concept of our anti-IL-6 immunotherapy in a phase 2 clinical trials in patients with inflammatory KOA. We expect to confirm our product’s safety, tolerance and ability to induce an anti-IL-6 immune response in treated patients, as well as demonstrate benefits in pain, function and limitation of disease progression. Results will be leveraged to sign an out-licensing agreement with a pharmaceutical company active in therapeutic areas of inflammatory diseases or osteoarthritis, with a global outreach.
Our therapy can change the way OA is treated today, by offering patients an affordable, safe and disease-altering therapy. From the point of view of healthcare systems, our treatment can save the EU billions in direct costs associated with OA, and maintain early-stage patients in the workforce. An effective treatment will also result in indirect cost savings stemming from recovered productivity and avoidance of OA complications that require additional healthcare resources for complimentary medications, GP visits and hospitalizations due to e.g. fractures and cardiovascular events, which are common complications in OA.
Finally, IL-6 overproduction is associated with ~40 other pathologies, related to ageing and chronic inflammation. Our anti-IL-6 therapy has thus many potential immediate applications besides osteoarthritis.