Sucampo Reports Phase 2a Trial Results Of Intravenous Ion Channel Activator

(RTTNews) - Sucampo Pharmaceuticals, Inc. (SCMP) reported the results of its double-blind, placebo-controlled Phase 2a proof of concept study assessing safety and efficacy of an intravenously or IV administered compound of the company's proprietary ion channel activator program in patients with lumbar spinal stenosis or LSS. A responder analysis of data from the study unveiled that patients receiving the ion channel activator experienced a statistically significant improvement in pain, as determined by improvements in the visual analog scale or VAS score, versus placebo.

Further, the company said there were improvements in the primary and other efficacy measures, including pain-associated quality of life measures for patients treated with the ion channel activator, though the extent of improvement was not statistically significant. The ion channel activator was well-tolerated and was not associated with serious adverse events. Moreover, no worsening of any of the efficacy measures in the active group was recorded.

"These findings suggest that our proprietary ion channel activator could have the ability to target and treat several aspects of lumbar spinal stenosis. We are pleased that these preliminary data show that this compound has the potential to improve pain, one of the major aspects of LSS, in a patient population with the condition," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive, and Chief Scientific Officer of Sucampo.

This multicenter, randomized, double-blind, placebo-controlled, dose-escalation trial enrolled 51 hospitalized patients between the ages of 20 and 75 with a confirmed diagnosis of lumbar spinal stenosis. Patients were administered 30 or 60 mcg of the ion channel activator or placebo twice daily for two weeks.