LEVALS study results assessing the effects of oral levosimendan in patients with ALS published

Results from LEVALS Phase 2 study assessing the effects of oral Levosimendan in patients with ALS were promising: in a research population of 66 patients, orally administered levosimendan was superior to placebo in improving breathing function.

The results of LEVALS Phase 2 study, in which the safety and efficacy of oral levosimendan (ODM-109) in patients with ALS was assessed have been published in a leading neurology journal, the Journal of Neurology, Neurosurgery and Psychiatry.

Though the primary endpoint was not reached, post hoc analyses revealed encouraging results: in 66 patients, supine (but not sitting) SVC was significantly higher after 14 days treatment on oral levosimendan (1 and 2 mg) compared to placebo. Levosimendan was well tolerated, the most common adverse events being headache and increased heart rate. The clinical effects of oral levosimendan are being confirmed in the ongoing REFALS phase 3 trial (NCT03505021) in patients with ALS.

Orally administered levosimendan is expected to improve breathing capacity and benefit overall daily functioning of ALS patients by enhancing respiratory muscle function.