NSL-043 Achieves Success in Phase I Multiple Ascending Dose Trial
· The study completed with no reports of serious or severe adverse events
· Overall, the adverse event profile of NSL-043 was consistent with that of placebo, except at the highest dose of NSL-043, where mild events consistent with the proposed therapeutic use of NSL-043 were observed
· The results significantly increase the value of NSL-043 project, bringing it one step closer to commercialisation
PERTH, Australia, July 21, 2008-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. 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.
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David McAuliffe – Executive Director
Iain Chessell – Chief Executive Officer
Fay Weston – Talk Biotech
T: +61 (0)408 994 313
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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.
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 2008, the Company successfully completed two Phase I trials for its development compound NSL-043, in partnership with Sosei Co. Ltd. Both of these trials reported a successful outcome, facilitating further development. The company has also commenced two Phase II trials for NSL-101 which will report in July 2008.
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 owns 100% of Sosei Co. Ltd. and Sosei R&D Ltd.
For further information about Sosei, please visit www.sosei.com<http://www.sosei.com/> Except for historical information, this news release may contain forward-looking statements that reflect the Company’s current expectation regarding future events. These forward looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company’s ongoing quarterly and annual reporting.
Appendix 1: Multiple Ascending Dose Phase I Trial Design & Details
Subjects: 36 healthy male subjects/ Non-smokers aged 18-50 years
Rationale: NSL-043 is a potential treatment for neuropathic pain. This study was undertaken to assess the safety, tolerability and pharmacokinetic profile of NSL-043 in healthy male subjects. The purpose of the trial is to satisfy regulatory safety requirements and to gather pharmacokinetic data that will facilitate the design of Phase II efficacy trials.
Blinding status: Double blind
Placebo controlled: Yes
Treatment route: Oral (capsules)
Study design: The study comprised four cohorts each containing nine subjects. The safety and tolerability of NSL-043 was determined by administration of multiple doses of the compound, or placebo to each cohort, with a division of 6 active and 3 placebo individuals in each cohort. Subjects received a single dose of test substance on day 1, followed by multiple doses (BID) of test substance on days 5-10. Subjects were not administered any test substance on days 2-4 inclusive
Dose cohorts: 0 (placebo), 100, 300, 600 and 2000mg, twice daily of NSL-043
Incidence of treatment emergent adverse events (TEAEs).
There were 22 TEAEs (Treatment-Emergent Adverse Events), distributed approximately evenly between the placebo (12 subjects, 7 TEAEs and NSL-043 (24 subjects, 15 TEAEs) groups. TEAEs which were different from placebo (all classified as mild) included parasthesia, a skin sensation of tingling, “pins and needles” and numbness, (3 reports), and hypoaesthesia , a loss of sensation following stimulation of the skin, (1 report) in the highest dose group, an observation entirely consistent with the intended therapeutic activity of NSL-043.
Laboratory safety tests, ECG and vital signs.
There were no significant drug related changes in laboratory safety tests
NSL-043 plasma concentration
Plasma drug concentration (AUC) increased over the dose range administered in an approximately proportional manner
Trial site: Single site in Merthyr Tydfil, UK.
Contract Research Organisation: Simbec Research Ltd
Fay Weston Director Talk Biotech T: +61 (0)2 4885 2662 M: +61 (0)422 206036 E:firstname.lastname@example.org
Posted: July 2008