Orion to present four posters on oral levosimendan in patients with ALS at the 30th International Symposium on ALS/MND

Orion to present four posters on oral levosimendan in patients with ALS at the 30th International Symposium on ALS/MND

Orion Corporation                        Press release                               2 December 2019 at 1.00 p.m. EET

Orion Corporation will present four posters on oral levosimendan at the 30^th International Symposium on ALS/MND held on 4–6 December 2019 in Perth, Australia. The presentations will include biomarker and pharmacokinetic data from previous studies such as the LEVALS phase 2 trial, a systematic literature review on pharmacological effects of levosimendan and baseline characteristics and status update on the progression of the ongoing REFALS phase 3 study.

The effects of Orion’s oral levosimendan on diaphragm function suggest a possible clinical value in treating patients with amyotrophic lateral sclerosis (ALS) and Orion has studied the effects of oral levosimendan on respiratory function in patients with ALS.

Respiratory decline is one of the biggest challenges in ALS and a major cause of disability, fatigue, morbidity and - eventually - mortality in ALS. There is currently no efficacious medicinal treatment for the respiratory problems, and patients have to rely on assisted ventilation when the symptoms get worse. Orion’s phase 2 LEVALS pilot study with 66 patients with ALS showed promising results as supine slow vital capacity (SVC), which reflects respiratory function, was better on levosimendan compared to placebo.

The following list of posters will be presented at the 30^th International Symposium on ALS/MND on 5^th of December, 2019

       ·Mechanism of action of the cardiovascular drug levosimendan in the management of amyotrophic lateral sclerosis ()¹

                            Session: Preclinical therapeutic strategies | 10:30-11:30 | Kira M. Holmström

       ·Baseline characteristics and status update of REFALS: a phase 3 study comparing oral levosimendan to placebo in patients with ALS ()²

                            Session: Clinical trials and trial designs | 10:30-11:30 | Chris Garratt                      

       ·Oral levosimendan for amyotrophic lateral sclerosis: pharmacokinetic considerations ()²

                            Session: Clinical trials and trial designs | 10:30-11:30 | Valtteri Aho

       ·Biomarker analysis in oral levosimendan phase 2 clinical trial LEVALS ()³

                             Session: Tissue Biomarkers | 11:30-12:30 | Kira M. Holmström

About levosimendan

Intravenous levosimendan is an inodilator that has been used to treat acute heart failure since 2000 and is approved in nearly 60 countries worldwide. Levosimendan was discovered in Orion in 1990’s. Phase 3 clinical trial REFALS (NCT03505021) studying the effects of oral levosimendan in patients with ALS is ongoing.

About Orion

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 2018 amounted to EUR 977 million and the company had about 3,200 employees at the end of the year. Orion's A and B shares are listed on Nasdaq Helsinki. For more information, go to .

Contact persons:

Taru Blom, MD, Vice President, Therapy Area CNS, Research and Development, Orion Corporation

Tel. +358 10 426 7836

Media Contacts:

Terhi Ormio

Vice President, Communications, Orion Corporation

Tel. +358 (0)50 966 4646

References

1. Abstract TST-43: (2019) Theme 7 Pre-clinical therapeutic strategies, Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 20:sup1, 217-245, DOI: 10.1080/21678421.2019.1646995
2. Abstracts CLT-18 ja CLT-26 (2019) Theme 9 Clinical trials and trial design, Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 20:sup1, 262-288, DOI: 10.1080/21678421.2019.1646997
3. Abstract BIO-11: (2019) Theme 6 Tissue biomarkers, Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 20:sup1, 206-216, DOI: 10.1080/21678421.2019.1646994

Publisher:

Orion Corporation

Communications

Orionintie 1A, FI-02200 Espoo, Finland