Neuropathic Pain - NSL-043 Achieves Phase I Trial Success

Main Category: Pain / Anesthetics
Article Date: 10 Apr 2008 - 2:00 PDT

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NeuroDiscovery Ltd (ASX: NDL), a specialty neuroscience services provider and drug development company, is pleased to announce the success of its Phase I clinical trial of NSL-043. This trial is the first of two Phase I trials, designed to test the safety and tolerability of an oral formulation of NSL-043. The second trial is ongoing, and both are being undertaken in collaboration with the Company's 50/50 partner, Sosei Group Corporation.

In this trial, healthy male volunteers were given a single dose of NSL-043 in capsule form. There were seven treatment groups, each with eight participants, who received from 10-2000mg of NSL-043. At random, one subject in four from each group was assigned a placebo (dummy pill). Adverse effects of the drug were not meaningfully different from placebo. The highest dose, of 2000mg, is five times higher than has previously been studied in humans, but NSL-043 was nonetheless well tolerated at all doses.

As well as monitoring for adverse events, this study has enabled NeuroDiscovery to assess the metabolism and pharmacokinetics of NSL-043 in humans. Additional data are expected by July 2008 from an on-going repeat-dosing (multiple ascending dose) Phase I trial of NSL-043. The data from these Phase I trials will enable the Company to begin a Phase II study, scheduled to commence in Q408.

"We are delighted to find further evidence that NSL-043 has an excellent safety profile," commented Dr Mark Treherne, the Chairman of NeuroDiscovery. "Before NeuroDiscovery initiated further development of NSL-043 for neuropathic pain, the compound had already completed clinical trials in Japan for a different indication, to the completion of phase II, with no safety issues that would preclude its further development".

"All information to date gives us confidence that this reprofiled compound may represent a real breakthrough for the treatment of neuropathic pain," Dr Treherne added. "These latest results bring us another step closer to realising that goal."

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 US$5.5 billion by 2010. 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.

About NeuroDiscovery

NeuroDiscovery Ltd is an ASX listed speciality neuroscience services provider and drug development company which owns 100% of NeuroSolutions Ltd (ASX Code NDL).

About NeuroSolutions

NeuroSolutions Limited is a profitable service company, which has applied its broad spectrum expertise and drug discovery platforms to become a leading provider of specialised electrophysiological assays to the biopharmaceutical industry. Electrophysiology is a specialised technique which is used to record electrical activity in membranes, cells or tissues. NeuroSolutions' current clients include many established pharmaceutical and biotechnology companies.

In parallel to running its service business, the Company is also exploiting its in-house technologies and expertise for its own internal R&D and has a mature pipeline of programmes underway for the treatment of pain.

During 2007, the company commenced two Phase I trials for its development compound NSL-043, in partnership with Sosei Group Corporation, a listed Japanese biopharmaceutical company. The first of these trials reported a successful outcome and the results of the second trial will be reported before June 30 2008. The company has also commenced two Phase II trials for NSL-101 which will report before June 30 in 2008.

NeuroSolutions

About Sosei

Sosei Group is a leading international biopharmaceutical company with significant expertise in product discovery and development. It has established a reduced risk business model primarily upon identifying new uses for established drugs and exploiting its unique position within Japanese, European and North American pharmaceutical markets by acquiring compounds from, and bringing compounds into, Japan.

Sosei Group