Neuropathic Pain - NSL-043 Achieves Success In Phase I Multiple Ascending Dose T

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Neuropathic Pain - NSL-043 Achieves Success In Phase I Multiple

Ascending Dose Trial

http://www.medicalnewstoday.com/articles/115770.php

NeuroDiscovery Ltd (ASX: NDL), a specialty neuroscience services

provider and drug development company, is pleased to announce the

successful completion of its Phase I multiple ascending dose clinical

trial of NSL-043. This trial is the second of two Phase I trials,

designed to test the safety, tolerability and pharmacokinetics of an

oral formulation of NSL-043 for the treatment of neuropathic pain.

Successful completion of the first, single ascending dose trial was

announced 9th April 2008 (Neuropathic Pain - NSL-043 Achieves Phase I

Trial Success). Both trials were undertaken in collaboration with the

Company's 50/50 partner, Sosei Co. Ltd.

In this trial, healthy male volunteers were given a repeated twice

daily dose of NSL-043 in capsule form for 10 days. There were four

treatment groups, each with nine participants, who received doses of

between 100-2000mg of NSL-043 or placebo twice daily. The adverse

event profile of NSL-043 demonstrated good safety and tolerability.

At the highest dose tested, there were reports of mild events on the

sensory system which may be consistent with the therapeutic use of

NSL-043.

As well as monitoring for adverse events, this study has enabled

NeuroDiscovery to assess the pharmacokinetics of NSL-043 in humans

after repeated oral dosing for 10 days. The concentration of NSL-043

found in patients overlapped with concentrations effective in

preclinical models of neuropathic pain, representing a discharge of

one of the major risks in clinical development.

The positive data from these Phase I trials facilitates the ongoing

enabling work required to examine the efficacy of the compound in

patients.

" We are delighted to find further evidence that NSL-043 has an

excellent profile. All information to date gives us confidence that

NSL-043 may represent a real breakthrough for the treatment of

neuropathic pain, " commented Dr Iain Chessell, the CEO of

NeuroDiscovery.

" These repeat dose safety and pharmacokinetic results continue to

enhance the value and potential of NSL-043 to the Company and bring

us another step closer to realising a significant a commercial

outcome for the Company, " Dr Chessell added.

About Neuropathic Pain

Neuropathic pain is associated with peripheral or central nervous

system injury, and can persist for months or years after the initial

insult. It is often described as " burning " or " shooting " in nature

and can be continuous or paroxysmal. It is estimated that up to 5% of

the general population of the USA, Europe and Japan are affected by

neuropathic conditions including diabetic neuropathic pain and post-

herpetic neuralgia.

The condition has a poor prognosis and is a significant cause of

morbidity. The neuropathic pain market is forecast to reach over

US$6.3 billion by the end of 2017 (Datamonitor 2008). Although there

is no single definition of neuropathic pain, approximately 26 million

patients worldwide suffer from some form of the condition (Espicom,

2005). As the currently available treatments for neuropathic pain

provide only partial pain relief, there is a strong need for new

agents with novel mechanisms of action that lead to improved drugs.