Stevenage, UK and Copenhagen, Denmark, September 17, 2020 – 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, 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 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. 1,2
For more information, please contact: David Miles CEO AKL Research & Development firstname.lastname@example.org
Sarah Wolf The Difference Collective T: 07747 7332216 email@example.com
Jeppe Ragnar Andersen CEO NBCD A/S jra@NordicBio.com
NOTES TO EDITORS:
· APPA is a patented fixed combination of two synthetically produced, synergistic, secondary metabolites of plant origin, which exerts its anti-inflammatory effect by modulating the pathways of intracellular signalling molecules, NFkB and Nrf2. Related to innate immune responses, APPA also inhibits the formation of neutrophil extracellular traps (NETs).
· APPA is unique because it directly affects inflammation at its source by re-balancing NFkB and Nrf2. APPA regulates rather than blocks the immune response, allowing the body to maintain host defence mechanisms.
· AKL Research & Development (AKLRD) Ltd’s primary focus is inflammatory diseases, particularly those related to the disruption of the immune system, such as OA.
· It identifies secondary metabolites of plant origin with proven efficacy and safety, which are then synthesised before undergoing standard pharmaceutical clinical development. This innovative approach greatly increases the chances of success, while reducing the likelihood of unexpected side effects.
· AKLRD is based at the Stevenage Bioscience Catalyst, Stevenage, Herts UK. For more information, visit us at: http://www.aklrd.com
· Nordic Bioscience Clinical Development (NBCD) is a Clinical CRO headquartered in Denmark which has, over the past 15 years, successfully managed all aspects of several phase I, II and III trials in osteoarthritis.
· It leverages its network of academic research partners, advisors and dedicated clinical research sites, and operates in the front-line of clinical research of this disease and is dedicated to making a true difference for the patients suffering from this debilitating disease.
· For more information about NBCD, visit us at: http://www.nbcd.com
· Osteoarthritis (OA) is a common, debilitating, degenerative disease of the joints involving the cartilage and its surrounding tissues1
· More than half of all people over the age of 65 have OA, and it is the third most rapidly rising condition globally, just behind diabetes and dementia2
· The FDA has recently classed OA ‘a serious disease’3
· It is the most common joint disorder in the United States, affecting more than 32 million adults4
· It is also the most common type of arthritis in the UK, affecting 8.75 million people, a number expected to more than double by 20305, 6
· The annual costs associated with OA in the USA are estimated to be $89.1billion, with between $3.4 billion and $13.2 billion of that expenditure solely to job-related OA, making it more costly than asthma and pulmonary diseases, and also more costly than renal and neurological diseases combined7
· The incidence of hand, hip and knee OA increases with age, and women are more commonly affected than men, especially over the age of 501
· Risk factors include obesity, joint abnormalities, occupation and genetics6
· The knee is most commonly affected, followed by the hip and hands/wrists8
· Cardiovascular disease and metabolic syndrome are other common co-morbidities, putting people with OA at increased risk of hospitalisation6,9
· There are no drugs approved for preventing or slowing OA disease progression; in other words, it has no cure10
· Patients typically rely on pain relief, including non-steroidal anti-inflammatory drugs (NSAIDs) and steroids to manage symptoms. But guidelines from the American Food and Drug Administration (FDA) and National Institute for Health and Care Excellence (NICE) in the UK stipulate these treatments should be taken at the lowest effective dose for the shortest possible amount of time because of their side effect profile. They can cause adverse events including bleeding from the stomach and intestine, and a 50-100 per cent increase in cardiovascular events, such as heart failure11,12
· A massive market need exists for an affective and well tolerated drug for OA pain
1 Litwic A, et al. Epidemiology and burden of osteoarthritis. Br Med Bull 2018. 105;1:185-199
2 Xing, D. et al. Osteoarthritis and all-cause mortality in worldwide populations: grading the evidence from a meta-analysis Sci. Rep. 6, 24393; doi: 10.1038/srep24393 (2016).
3 FDA: Osteoarthritis - Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment Guidance for Industry. 18 Jul 2018.
5 NICE. SCOPE. Osteoarthritis: the care and management of osteoarthritis
6 Versus Arthritis. State of Musculoskeletal Health 2019. https://www.versusarthritis.org/media/14594/state-of-musculoskeletal-health-2019.pdf [Accessed 7 August 2020]
7 Leigh JP, Seavey W, Leistikow B. Estimating the costs of job related arthritis. J Rheumatol. 2001;28(7): 1647- 1654
8 NICE. SCOPE. Osteoarthritis: the care and management of osteoarthritis. https://www.nice.org.uk/guidance/gid-ng10127/documents/final-scope [Accessed 7 August 2020]
9 Schellevis FG, van der Velden J, van de Lisdonk E, van Eijk JT, van Weel C. Comorbidity of chronic diseases in general practice. Journal of clinical epidemiology 1993;46:469-73.
10 Sokolove J, Lepus CM. Role of inflammation in the pathogenesis of osteoarthritis: latest findings and interpretations. Ther Adv Muscloskelet Dis. 2013 5(2):77-94
11 NICE. Osteoarthritis: care and management. February 2014
12 CNT Collaboration, The Lancet, volume 382, No. 9894, p769–779, 31 August 2013