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.
