Phase III REFALS trial of Simdax fails to meet endpoints in amyotrophic lateral sclerosis.- Orion
Orion’s phase III REFALS trial evaluating the efficacy of oral Simdax (levosimendan) in treatment of amyotrophic lateral sclerosis (ALS) patients did not reach its pre-specified endpoints. Orion has completed the clinical phase III REFALS trial evaluating the efficacy and safety of oral levosimendan in the treatment of ALS (amyotrophic lateral sclerosis). The primary endpoint of the trial was to show a statistically significant difference between levosimendan and placebo in slow vital capacity (SVC) in supine position at 12 weeks compared to the baseline.
An important secondary endpoint was to show a statistically significant difference between levosimendan and placebo in patient functionality measured by ALSFRS-R Scale (Revised Amyotrophic Lateral Sclerosis Functional Rating Scale) in combination with survival at 48 weeks compared to the baseline. These pre-specified endpoints were not met in the trial. No new safety concerns were identified for levosimendan in this study. The REFALS phase III trial data will be presented at a future scientific meeting.