Tokyo, Japan – 8 December 2008: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), a biopharmaceutical company, today announces the successful results of two Phase I trials for its collaborative project on SD118, a compound in development for the treatment of neuropathic pain.
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. Now, following animal model studies conducted in Sosei’s Drug Reprofiling Platform (DRP), it has demonstrated potential as a new oral neuropathic pain therapy.
The Phase I trials were both double-blind, placebo-controlled, dose escalation studies designed to evaluate the safety, tolerability and pharmacokinetics of SD118 administered in an oral formulation.
In the first trial, a single ascending dose (SAD) study conducted in 56 healthy male volunteers, no serious adverse events (SAEs) were reported in any of dose ranges including the highest dose used in the study. Notably, the plasma concentration of SD118 increased proportionately with administered doses of the drug across the entire dose range investigated. Consequently,, SD118 was considered to be safe and well tolerated in doses up to 2000mg..
In the second trial, a multiple ascending dose (MAD) study conducted in 36 healthy male volunteers, no SAEs were reported and SD118 was considered safe and well tolerated. At the maximum dose of 2,000mg BID, nervous system related adverse events were reported, paraesthesia by four subjects, and hypoaesthesia by one subject, but there were no concerns regarding clinical safety. In this study the pharmacokinetic profile also showed a plasma concentration increase in proportion to doses of SD118 from 100mg BID to 2,000mg BID.
Mr Shinichi Tamura, President & CEO of Sosei, said: "I am delighted that SD118 demonstrated a good safety profile, especially considering the wide range of doses tested. This project is now ready to move into the next step of development.”