Sosei Group Corporation has announced 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 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 Authorization) 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 analyzed.
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."