Levosimendan (ODM-109)

What does the drug do?

Levosimendan (ODM-109) is licensed to treat some forms of congestive heart failure by strengthening the action of heart muscle. The trial is investigating whether the drug might also have some usefulness in MND by helping to improve the function of the diaphragm muscle, one of the main muscles involved in breathing.

Phase 2 (LEVALS)

The Phase 2 trial (LEVALS) failed to effectively demonstrate levosimendan’s ability to promote changes in slow vital capacity when sitting, but showed improved breathing function in participants in the supine position taking levosimendan compared to those taking placebo. It was also shown to be safe and well tolerated. You can read more about the trial here.

Phase 3 (REFALS)

The Phase 3 trial (REFALS) enrolled 496 participants across 104 sites in the United States, Canada, Europe, and Australia. The primary objective of the trial was to show that the drug levosimendan enhances respiratory muscle function and thus helps maintain breathing capacity in people with MND. Unfortunately, the trial did not reach its pre-specified endpoints. You can find out more about the trial here.

An open-label extension study (REFALS-ES) was also started to provide an opportunity for all participants to continue treatment with oral levosimendan to evaluate long-term safety. No new safety measures were identified. The study also showed a decline in all the efficacy outcome measures. You can find out more about the OLE here.

Trial Outcome

Levosimendan did not meet its pre-specified endpoints to show benefit in people living with MND. You can read more about the results here.

Resources

Want to find out more about Levosimendan? Check out the resources below:

Blogs:

Update on clinical trials - part 1

Virtual Symposium: Phase 3 clinical trial results - levosimendan

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