What does the drug do?
Edaravone was originally developed to treat acute ischemic stroke, however it was then tested in people with MND. One theory about why motor neurones die in MND is that they are affected by oxidative stress. Cell’s normal metabolic processes can cause oxidative stress. This can result in cellular damage resulting in excessive accumulation of free radicals. Edaravone acts as a ‘free radical scavenger’ helping to reduce the effects of oxidative stress and hopefully slow the progression of MND.
Trial Outcome
The Phase 3 (ADORE) clinical trial was investigating a formulation of oral edaravone, known as FNP122. This trial did not meet its primary or secondary endpoints. There was no significant difference in the change in ALSFRS-R (from baseline to 48-weeks) for those who received the treatment compared to those who received the placebo (dummy drug). There was also no improvement in long-term survival when comparing FNP122 to placebo over 72-weeks. This data suggests that FNP122 is not beneficial for people with MND. You can read more in a press release.
Previous Clinical Trials
Phase 3 (ADORE)
The Phase 3 (ADORE) clinical trial investigated a formulation of oral edaravone, known as FNP122. The trial was randomised, double-blind and placebo controlled. It recruited around 300 participants with the support of TRICALS, the largest European research initiative to find a cure for ALS. The trial did not meet its primary or secondary endpoints, suggesting that it FNP122 is not benefical for people with MND. You can find out more about the trial here.
Latest News
2022
Nov 2022 - The trial closed for recruitment.
2021
Nov 2021 - The trial began recruiting in Europe.
2024
January - The trial did not meet its primary or secondary endpoints, suggesting it is not beneficial for people living with MND. The open-label extension (where everyone receives the treatment) will end due to the lack of benefit observed.
Resources
Blog Posts
The Scientific Advisory Council (SAC) Briefing Notes
The Scientific Advisory Council for the International Alliance of ALS/MND societies consists of 9 members from USA, UK (including MND Association's Head of Research - Dr Nick Cole), Sweden, Italy, South Africa, China, Australia and Canada.
They produce briefing notes as a trusted source of information about current experimental treatments in clinical development, such as Oral Edaravone.
These notes are produced after many rounds of careful discussion between the SAC members.
You can find the briefing note for Oral Edaravone here.
Last updated: 10/01/2024