TruNoc^™ – Neuropathic Pain

Neuropathic pain, also known as nerve pain and neuropathy, is associated with a functional abnormality of the nervous system. It is caused by a primary lesion or dysfunction of the nervous system (either peripheral or central) and the nerve fibers themselves may be damaged, dysfunctional or injured. The damaged nerve fibers send incorrect signals to other pain centers. The impact of nerve fiber injury includes a change in nerve function both at the site of injury and areas around the injury. Due to the complex nature of neuropathic pain, standard analgesics have little effectiveness.

Neuropathic pain is a debilitating condition characterized by severe, relentless, chronic nerve pain and is often a complication of conditions including diabetes, herpes simplex virus infection, cancer, HIV infection, multiple sclerosis, stroke, traumatic injury or surgery. The symptoms that patients experience are often described as burning, tingling or shock-like sensations. Neuropathic pain is often under-identified and under-treated. Some sufferers are unable to work, walk or even wear clothes as the contact with their skin can cause an unbearable burning pain. Correct diagnosis is critical because treatments that may be effective in other types of pain often do not provide relief for neuropathic pain patients.

TruNoc (tarenflurbil)
Nitec in-licensed TruNoc (tarenflurbil) from PAZ GmbH in 2007 and is conducting pharmacokinetic studies in preparation for further clinical development of TruNoc at higher doses. These 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 neuropathic pain thereafter. The initial areas of focus are likely to be in neuropathic pain related to diabetes, HIV and herpes virus infection, with diabetic-related neuropathic pain likely to be the first indication to be investigated.

Market size
The size of the neuropathic pain market in 2006 was estimated to be over US$ 2.5bn and is expected to grow over 10 % per year to over US$ 7bn by 2016. It was estimated that over 1.5 million people currently suffer from neuropathic pain in the seven major pharmaceutical markets (the US, Japan, France, Germany, Italy, Spain and the UK). The growth is predominantly being driven by new therapies coming to the market, as well as an increase in prevalence of diabetes and HIV with patients living longer. In 2007, across the seven major pharmaceutical markets, it was estimated that the 2006 patient populations with neuropathic pain related to diabetes, post herpes and HIV were 660,000, 283,000 and 550,000, respectively.