Orion, a Finnish pharmaceutical company, has hired the first patients in a phase three clinical trial named REFALS, to assess orally administered levosimendan (ODM-109) intended for the treatment of symptoms of amyotrophic lateral sclerosis (ALS), it was reported yesterday.
The aim of the trial is to showcase that orally administered levosimendan, by improving respiratory muscle function, can help maintain breathing capacity and so benefit overall functioning of patients with amyotrophic lateral sclerosis.
The company is hiring a total of 450 patients 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. The company is investing around EUR60m in the study over approximately three years.
If the trial provides positive results, it is the company's intention to file for marketing authorisation in the United States and Europe.
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