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.”
