Periodic Reporting for period 1 - Anti-IL-6 (A breakthrough active immunotherapy for the treatment of osteoarthritis)
Reporting period: 2024-03-01 to 2025-02-28
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.
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.
Since the start of the project, Peptinov has performed the activities leading to the start of the phase 2 clinical trial in knee osteoarthritis patients:
1. Preparation and submission of the CTA (Clinical Trial Authorization) regulatory file, submitted on Aug 19th 2024 to the regulatory authorities of the five European countries in which the trial is planned (Czech Republic, Denmark, France, Poland, Romania). During the evaluation process, the regulatory authorities requested information/answers to 77 questions to which Peptinov and its collaborators provided answers in very short delay (10 days for the first round of 56 questions and a few days for a second round of 21 questions). The questions/requests for information from the regulatory authorities were on different subjects: trial protocol, documentation, CMC (Chemistry, Manufacturing & Controls) aspects, etc. A conditional approval was issued in December 2024, requesting an amendment to the study protocol and patient informed consent form. The amendments were submitted in January 2025 and the full approval is expected by early April .
2. Preparation of the clinical trial, in collaboration with the CRO (Clinical Research Organization) which will manage the trial for Peptinov, NBCD located in Denmark, which has a renowned expertise in osteoarthritis. Preparation work included vendor selection and setup, clinical trial systems setup (e.g. ePRO, eDiary), supply chain setup and management, production of the clinical batch, clinical site selection, investigator meeting with the clinicians (held in Berlin on Nov 07-08th), production of documentation for the clinical teams.
1. Preparation and submission of the CTA (Clinical Trial Authorization) regulatory file, submitted on Aug 19th 2024 to the regulatory authorities of the five European countries in which the trial is planned (Czech Republic, Denmark, France, Poland, Romania). During the evaluation process, the regulatory authorities requested information/answers to 77 questions to which Peptinov and its collaborators provided answers in very short delay (10 days for the first round of 56 questions and a few days for a second round of 21 questions). The questions/requests for information from the regulatory authorities were on different subjects: trial protocol, documentation, CMC (Chemistry, Manufacturing & Controls) aspects, etc. A conditional approval was issued in December 2024, requesting an amendment to the study protocol and patient informed consent form. The amendments were submitted in January 2025 and the full approval is expected by early April .
2. Preparation of the clinical trial, in collaboration with the CRO (Clinical Research Organization) which will manage the trial for Peptinov, NBCD located in Denmark, which has a renowned expertise in osteoarthritis. Preparation work included vendor selection and setup, clinical trial systems setup (e.g. ePRO, eDiary), supply chain setup and management, production of the clinical batch, clinical site selection, investigator meeting with the clinicians (held in Berlin on Nov 07-08th), production of documentation for the clinical teams.
As described above, Peptinov has successfully submitted the CTA file to the regulatory authorities for its phase 2 clinical trial in osteoarthritis. Questions/Requests for Information from the regulatory authorities were answered in due delay, resulting in a conditional CTA approval issued in December 2024. The requested protocol modifications from the authorities were performed and the file was resubmitted. Final approval should arrive in April.
In the meantime, Peptinov performed the necessary clinical trial preparation steps: production of the clinical batch, vendor selection, clinical sites selection, systems setup, investigator meeting, etc.
Finally, we established connections with institutional investors in the healthcare sector in order to secure funding for the equity-financed portion of the project. Additionally, we engaged with pharmaceutical groups that have shown interest in our technology and could potentially become industrial partners upon the project's success.
In the meantime, Peptinov performed the necessary clinical trial preparation steps: production of the clinical batch, vendor selection, clinical sites selection, systems setup, investigator meeting, etc.
Finally, we established connections with institutional investors in the healthcare sector in order to secure funding for the equity-financed portion of the project. Additionally, we engaged with pharmaceutical groups that have shown interest in our technology and could potentially become industrial partners upon the project's success.