Orion Oyj: Orion intents to start an open label extension study to the REFALS phase 3 trial studying the effect of oral levosimendan in patients with ALS

Orion Corporation Press release 4 February 2019 at 10.00 a.m. EET

Orion intents to start an open label extension study to the REFALS phase 3 trial studying the effect of oral levosimendan in patients with ALS

Orion Corporation announces the intention to start an open label extension study to the ongoing phase 3 trial, REFALS, studying the effects of oral levosimendan (ODM-109) on respiratory function in patients with amyotrophic lateral sclerosis (ALS). The extension study, to be known as REFALS-ES, will provide an opportunity for all applicable patients completing the REFALS study to receive oral levosimendan treatment for as long as it is clinically required. The study will provide valuable information on long-term safety and effectiveness of oral levosimendan in patients with ALS.

"Oral levosimendan has potential to make an important contribution to treating patients with ALS in the future and it's really great that Orion is making this long-term commitment to the patients taking part in that research" said Professor Merit Cudkowicz, Director of the Healey Center for ALS at Masachusetts General Hospital, the Lead Investigator in the REFALS and REFALS-ES studies.

REFALS

REFALS is ongoing and will enroll altogether 450 participants across 105 sites in the U.S., Canada, EU and Australia. The patients will be treated for around one year after the first administration of the drug. 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. Patient enrolment is expected to continue until early summer 2019.

Levosimendan

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 almost 60 countries.

ALS as a rare neurogenerative disease

ALS is a rare adult-onset neurodegenerative disease of upper and lower motor neurons resulting in progressive weakness, with death occurring from respiratory failure commonly as a result of diaphragmatic weakness typically within three to four years of diagnosis. Poor respiratory function is a major source of disability, fatigue, morbidity and mortality in ALS.

More information about the REFALS Phase III study: www.clinicaltrials.gov, Indentifier: NCT03505021 (https://www.clinicaltrials.gov/ct2/show/NCT03505021?term=NCT03505021&cond=ALS&rank=1)

Further information:

Taru Blom
Vice President, Therapy Areas CNS, Easyhaler and AH
Tel. [phone]
[e-mail]

Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
www.orion.fi

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 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.

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Source: Orion Oyj via Globenewswire