Co announced the results of its double-blind, placebo-controlled Phase 2a proof of concept study evaluating safety and efficacy of an intravenously (IV) administered compound of the company's proprietary ion channel activator program in patients with lumbar spinal stenosis (LSS). A responder analysis of data from the trial revealed that patients receiving the ion channel activator experienced a statistically significant improvement in pain, as determined by improvements in the visual analog scale (VAS) score, versus placebo (94.4% versus 62.5%; p=0.035).
Improvements were also observed in the primary and other efficacy measures, including pain-associated quality of life measures for patients treated with the ion channel activator, although the extent of improvement was not statistically significant.
The ion channel activator was well-tolerated and was not associated with serious adverse events. Additionally, no worsening of any of the efficacy measures in the active group was recorded.
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