Demonstrating chondroprotective, anti-inflammatory, and analgesic activity of IL4-10FP in osteoarthritis
Synerkine Pharma’s fusion protein IL4-10FP was concidered the first drug that met the criteria of a disease-modifying OA drug (DMOAD). This project investigated IL4-10FP to determine its dose-dependence and pharmacokinetic properties, crucial for a first-in-human (FiH) study.
Societal and Economic Impact
Osteoarthritis (OA) is a significant global health concern, leading to chronic pain, reduced mobility, and substantial healthcare costs. The World Health Organization reported that OA affects 10% of men and 18% of women over 60 years old. In the United States, the economic burden of OA was estimated at $136.8 billion annually. Innovative treatments like IL4-10FP have the potential to alleviate symptoms, reducing healthcare costs, and improving the quality of life for OA patients.
Project Approach and Conceptualization
The project was divided into two main work packages (WPs). WP1 assessed the concentration-dependent chondroprotective effects of IL4-10FP by measuring proteoglycan turnover in human OA cartilage explants. WP2 evaluated the disease-modifying osteoarthritis drug (DMOAD) properties and pharmacokinetic characteristics of IL4-10FP following intra-articular administration in a dog model of OA. This dual approach ensures a comprehensive understanding of IL4-10FP’s therapeutic potential.
Deliverables and Results
The project began with ethical approval applications, receiving positive feedback by November 2020. WP1 started in early 2021, but initial experiments showed that the newly formulated IL4-10FP did not perform as expected. Despite several experimental adjustments in follow-up experiments, no efficacy of IL4-10FP in altering proteoglycan turnover in OA cartilage could be demonstrated. Evaluations of different batches and additional controls did not yield statistically significant results, indicating no clear effects of IL4-10FP. Consequently, testing in canine models was deemed unfeasible and unethical.
It was concluded that IL4-10FP, in its current form, did not provide the anticipated therapeutic benefits for OA, highlighting the complexities and challenges of developing effective biopharmaceutical treatments.
