Finnish pharmaceutical company Orion Corp (HEX:ORNAV) has recruited the first patients in its Phase III clinical trial of orally administered levosimendan (ODM-109) for the treatment of symptoms of amyotrophic lateral sclerosis (ALS), also known as motor neurone disease (MND) or Lou Gehrig's disease, the company reported on Friday.
A total of 450 patients will participate in the placebo-controlled trial at around 100 clinical sites in Europe, North America and Australia. The trial aims to demonstrate that orally administered levosimendan, by enhancing respiratory muscle function, can help maintain breathing capacity and so benefit overall functioning of ALS patients.
Although levosimendan does not cure ALS, it is expected to maintain the patient's breathing capacity for longer -- improving quality of life by delaying the need for ventilation support.
Orally administered levosimendan has been granted orphan drug designation by regulators in the United States and the European Union.
Patients taking part in the study will be treated for around one year after the first administration of the drug.
If the results are positive, Orion plans to file for marketing authorisation in the US and Europe.
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