ESPOO, Finlandn I July 6, 2018 I Orion has recruited the first patients in the Phase III clinical trial (REFALS) in which orally administered levosimendan (ODM-109) is being evaluated for the treatment of symptoms of amyotrophic lateral sclerosis (ALS). The purpose of the trial is to demonstrate that orally administered levosimendan, by enhancing respiratory muscle function, can help maintain breathing capacity and so benefit overall functioning of patients with ALS.
ALS is a rapidly progressing, fatal neurological disease that causes the death of motor neurons, leading to the weakening of voluntary muscles and eventually paralysis. There is no cure for ALS, and death commonly occurs within 3-5 years of diagnosis, typically due to respiratory failure. Levosimendan does not cure ALS, but it is expected to maintain the patient’s breathing capacity for longer and thus improve the quality of life by delaying the need for ventilation support.
A total of 450 patients will participate in the placebo-controlled trial at around 100 clinical sites in Europe, North America and Australia. The patients will be treated for around one year after the first administration of the drug. Orion is investing around EUR 60 million in the study over approximately three years. If the results of the trial are positive, the aim is to file for marketing authorisation in the United States and Europe. Orally administered levosimendan has been granted an Orphan Drug Designation both in the United States and in the European Union.
Phase II clinical trial (LEVALS)
The Phase II clinical trial (LEVALS) was completed in 2016. The results were promising: in a research population of 66 patients, orally administered levosimendan was superior to placebo in improving breathing function.
Levosimendan is a molecule originally developed by Orion for the treatment of acute decompensated heart failure. Launched in 2000, the Simdax® injection continues to be one of Orion’s largest products by sales value. It is being sold in more than 60 countries.
ALS as a rare disease
ALS is a rare disease, with an incidence of one to two cases per 100,000 people. In 2017, the total number of ALS patients was around 16,800 in the United States and around 12,500 in Europe. About 450-500 people in Finland suffer from ALS. Around 140 cases are detected each year in Finland, meaning that two or three people per week are diagnosed with ALS.
More information about the study: www.clinicaltrials.gov, Indentifier: NCT03505021
Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion’s pharmaceutical R&D are central nervous system (CNS) disorders, oncology and respiratory diseases for which Orion develops inhaled Easyhaler® pulmonary drugs. Orion’s adjusted net sales in 2017 amounted to EUR 1,034 million and the company had about 3,200 employees. Orion’s A and B shares are listed on Nasdaq Helsinki.