AKL Research & Development and Nordic Bioscience Collaborate to Take Novel Osteoarthritis Medicine to Phase II

TORONTO, May 2, 2019 /PRNewswire/ -- AKL Research & Development (AKLRD) and Nordic Bioscience Clinical Development, today announce a risk-share agreement to assess the efficacy of a novel, oral medicine, APPA, in a phase II trial of Osteoarthritis (OA). The collaboration is being announced at the Osteoarthritis Research Society International (OARSI) World Congress 2019 which starts today in Toronto, Canada.

The partnership will assess the effectiveness of APPA both in relieving OA pain and in slowing the destruction of cartilage, which has already been demonstrated in animal studies.^[1],[2],[3]. 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.^[4],[5],[6]

Jeppe Ragnar Andersen, CEO of Copenhagen-based Nordic Bioscience Clinical Development, says: "As experts in applied precision medicine and clinical trials in osteoarthritis, we are keen to assess APPA's ability to modify disease and regulate the inflammation cascade.

"It is clear to us that APPA has the potential to address the unmet need in OA. APPA is unique because it may not only stop the severe pain caused by OA but also prevent its progression, which can eventually destroys joints. This makes it an exciting possibility in a condition that has few treatment options available, none of which can currently stop further harm from occurring."

APPA is a synergistic combination of two synthetic secondary metabolites of plant origin. APPA exerts its anti-inflammatory effect by modulating pathways of the intracellular signaling molecules nuclear factor kappa beta (NFkB) and nuclear factor erythroid 2-related factor 2 (Nrf2). APPA directly affects inflammation at its source by regulating, rather than blocking, these two signaling molecules, preventing a cascade effect which can result in cartilage damage.

David Miles, CEO of UK-based AKLRD, says: "There is a desperate need for an effective and well-tolerated new treatment for osteoarthritis as it's a condition which blights the lives of millions of people globally.

"We have seen in animal studies that APPA appears to not only reduce pain but also put the brakes on cartilage degeneration so it's exciting to see if this is repeated in the forthcoming phase II trial. We have no doubt that Nordic Bioscience's unique expertise will help bring us a step closer to addressing this major global health issue."

APPA, developed by AKLRD, is currently undergoing a Phase I trial and is scheduled to finish this summer. The Phase II trial will begin shortly after in Copenhagen, with results expected mid-2020.

NOTES TO EDITORS:

• David Miles, CEO of AKL Research & Development and Jeppe Ragnar Anderson, CEO of Nordic Bioscience Clinical Development are in attendance at the OARSI congress and available for further comment. Contact Sarah Smith on [phone] to arrange.

About APPA

• As we age there is a greater potential for the body's inflammatory response to malfunction, initiating a cascade of activity that can result in chronic, degenerative diseases of inflammation, such as OA. The 'holy grail' of anti-inflammatory targeting is to block these tissue-damaging activities without compromising host defence mechanisms.
• 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 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 mechanisms¹. There are currently no licensed drugs available for human use that offer efficacy and long-term safety in OA.
• Journalists can request the "About APPA" Backgrounder and also a "APPA Mode of Action" Graphic for more information.

References

1. Cross A, et al. Effects of APPA on human neutrophil function. 2016 OARSI, Volume 24, S335 - S336
2. Larkins N, King C. E?ectiveness of APPA for the management of osteoarthritis in dogs: comparisons with placebo and meloxicam in client-owned dogs. 10.19185/Matters.201608000001
3. Glasson S, Bendele A, Larkins N. APPA provides disease modification in preclinical osteoarthritis. Planta Medica. 78. 10.1055/s-0032-1320902
4. Litwic A, et al. Epidemiology and burden of osteoarthritis. Br Med Bull 2018. 105;1:185-199
5. 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).
6. Arden N. OA is a serious disease. Presented at: OARSI 2018 World Congress on Osteoarthritis; April 26-29; Liverpool, England
   

For more information, please contact:

Sarah Smith
Associate Consultant
The Difference Collective
T: [phone]
[e-mail]

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