americanpharmaceuticalreviewMay 08, 2019
Tag: efficacy , Oral Medicine , APPA
AKL Research & Development (AKLRD) and Nordic Bioscience Clinical Development, announced a risk-share agreement to assess the efficacy of a novel, oral medicine, APPA, in a phase II trial of Osteoarthritis (OA).
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. 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.
"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," Jeppe Ragnar Andersen, CEO of Copenhagen-based Nordic Bioscience Clinical Development, said. "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.
"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," David Miles, CEO of UK-based AKLRD, said. "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.
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