TruNoc^™ – Osteoarthritis

Osteoarthritis (OA) is the most common form of arthritis and a major cause of pain and morbidity. As opposed to rheumatoid arthritis (RA), OA is not an autoimmune disease but is a degenerative joint disease, often characterized as ‘wear and tear’ whereby the ‘wear and tear’ leads to inflammation. The inflammation associated with OA results in pain in the joints, which is caused by wearing of the cartilage that covers and acts as a cushion inside joints, and destruction or decrease of synovial fluid that lubricates those joints. As the bone surfaces become less well protected by cartilage, the patient experiences pain upon weight-bearing actions such as walking and standing.

OA affects all adult age groups, but the elderly are the most affected. Women are also more likely to be affected by OA than men. It is estimated that 80 % of the world population will have radiographic evidence of OA by age 65, although only 60 % of those will be symptomatic. OA impacts not only individuals, but also the overall economy. It has been estimated that the annual cost of OA to the US economy is US$ 60 billion. Similarly, in the UK it has been estimated that 206 million working days were lost to arthritis (both OA and RA) in 1999-2000, which equates to a productivity loss of GB£ 18 billion.

The exact cause of OA is not known, but is believed to be related to a combination of genetic pre-disposition and overuse of the joints.

TruNoc (tarenflurbil)
Nitec licensed in TruNoc (tarenflurbil) from PAZ GmbH in 2007 and is conducting pharmacokinetic studies in preparation for further clinical development of TruNoc in higher doses. The phase 1 studies are also likely to include an additional pain model to demonstrate proof of concept. Nitec expects to conduct a phase 2 proof of concept trial for TruNoc in osteoarthritis thereafter.

Market size
In the Western population, OA prevalence is estimated to be 11-14 % with the total OA population across the seven major pharmaceutical markets (the US, Japan, France, Germany, Italy, Spain and the UK) estimated at 89 million. The withdrawal of Vioxx from the global market in September 2004 had a negative effect on the COX-II class, which saw total sales in the US and five major EU markets fall by 44 % from US$ 1.2bn to US$ 700m between 2004 and 2005. However, as patients sought alternatives to COX-II for the treatment of OA, total sales of the other OA classes used to treat OA saw positive growth. Overall, in 2005, the OA market was worth just under US$ 4bn, up 1.1 % from 2004.