A novel, oral osteoarthritis (OA) medicine being developed by AKL Research and Development (AKLRD) has recruited its first patient into its Phase II human clinical trial being conducted by its partner Nordic Bioscience Clinical Development (NBCD), following the successful completion of Phase I.
David Miles, CEO of UK-based AKLRD, says:
“Osteoarthritis is a debilitating condition which has a devastating impact on the daily lives of millions of people. Moving to a Phase II trial is a major milestone in the development of APPA and we are pleased that NBCD, a world-leading OA clinical research group, will bring its expertise to this next stage and move us closer to making APPA available to patients with OA. This disease is a major global health issue and we cannot underestimate the need for new treatments which are effective and well-tolerated.”
The study is a placebo-controlled, double-blind, randomised 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 research centres (Sanos Clinic) in Denmark, with results expected mid-2021.
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.
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.”
APPA is an oral, patented, fixed-dose combination of two synthetic secondary metabolites of plant origin – apocynin (4-hydroxy-3-methoxyacetophenone) and its isomer paeonol (2-hydroxy-4-methoxy-acetophenone). As an NFkB and Nrf2 gene transcription modulator, APPA provides its anti-inflammatory effect by regulating the cross-talk between these two signalling molecules in the inflammatory process.
OA is a degenerative disease of the joints affecting more than half of all people over the age of 65 and is the third most rapidly rising condition worldwide.
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