Sosei Announces Update on Phase I Trials for SD118
TOKYO, November 27 -- Sosei Group Corporation, a biopharmaceutical company, today announces an update on the status of its collaborative project SD118, which is under development for the treatment of neuropathic pain. SD118 has commenced a multiple dose ascending Phase I study and the initial single ascending dose Phase I study to explore higher doses has been extended.
SD118 is being jointly developed with NeuroDiscovery Ltd (ASX Code: NDL) and its wholly owned subsidiary NeuroSolutions Ltd under a Collaboration Agreement concluded in June 2006. SD118 was previously under investigation in Japan for a different indication and now, following re-profiling and evaluation in experimental animal models, has demonstrated its potential as a new oral therapy for neuropathic pain.
The latest study is a double blind, placebo controlled, multiple dose, sequential group, dose escalation trial in healthy male volunteers to assess the safety, tolerability and pharmacokinetic profile of SD118 administered as an oral capsule. The study, involving some 36 subjects in 4 cohorts, is being conducted in a single centre in the UK under a CTA (Clinical Trial Authorisation) regulatory approval.
Additionally, in recognition of the drug's emerging positive safety profile and the successful completion of the original trial protocol, it has been decided to extend the previously announced single dose Phase I study to explore additional higher doses. Regulatory approval has been obtained for this trial extension. A further announcement will be made when the extension phase is completed and all the study results are fully analysed.
Mr Shinichi Tamura, President & CEO of Sosei, said: "I am delighted that clinical development of SD118 continues to make good progress. This project has the potential to provide a valuable addition to currently available therapies in an area of notable unmet medical need."
Notes for Editors:
About Neuropathic Pain
Neuropathic pain refers to pain related to peripheral or central nervous system injury and can persist for months or years after the initial insult. 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.
Sosei Group Corporation 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.
For further information about Sosei, please visit http://www.sosei.com
NeuroDiscovery Ltd is an ASX listed neurology research and development company which owns 100% of NeuroSolutions Ltd (ASX Code: NDL).
For further information visit http://www.neurodiscoveryltd.com.
NeuroSolutions Limited is a profitable service company, applying its broad 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, tissues or in vivo. NeuroSolutions current clients include many other 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 has commenced Phase I trials on its lead compound NSL-043 in partnership with Sosei Group Corporation, a listed Japanese biopharmaceutical company. In addition Phase II trials for its other lead programme NSL-101 have commenced to explore its utility in dental pain.