Phase II osteoarthritis clinical trial underway

The APPA Phase II human trial is being conducted at three sites in Denmark by Nordic Bioscience Clinical Development (NBCD), AKL’s risk share partner, following the successful completion of Phase I. The study is a placebo-controlled, double-blind, randomized trial evaluating the efficacy and safety of oral APPA in 150 patients with osteoarthritis of the knee and is being conducted by NBCD at three clinical centres in Denmark, with results expected 2Q 2021. Jeppe Ragnar Andersen, CEO of Copenhagen-based NBCD, says: “This is the next step in an exciting partnership which will not only assess whether APPA can treat the pain of OA but will also provide early insights into APPA’s] ability to reduce cartilage degradation, something which currently licensed treatments cannot do. We believe APPA has huge potential to transform the treatment of OA and prevent millions from suffering chronic, daily pain and often crippling disability. The primary objective of the study is to evaluate changes in pain in the target knee as measured by the WOMAC score – a widely used, self-administered health status measure used to assess pain, stiffness and function in patients with OA of the hip or knee. Secondary objectives of the study include evaluating the safety and tolerability of APPA, changes in symptoms of OA, changes in physical functioning and changes in quality of life. Exploratory Objectives include changes in biomarkers associated with APPA’s effect on reducing cartilage degradation. A National Institute for Health Research (NIHR)-approved Phase I study was successfully completed earlier this year at the University of Liverpool in the UK. The full study report will be available shortly. More information can be found here.