Negative results from Phase 3 ADORE clinical trial of Oral Edaravone (FAB122) in ALS

Updated on: January 31, 2024

January 12, 2024 – Pharmaceutical company Ferrer has announced topline results from the ADORE (ALS Deceleration with ORral Edaravone) clinical trial in ALS. The Phase 3 study, conducted in Europe, investigated the efficacy of an oral formulation of edaravone (FAB122) over a 48-week period. The study did not meet primary or key secondary endpoints.

The results indicate no significant benefit from daily treatment with the oral edaravone formulation (FAB122) compared to placebo, as measured by changes in the ALS Functional Rating Scale-Revised (ALSFRS-R) score. Long-term survival, measured by the Combined Assessment of Function and Survival (CAFS), also showed no improvement. Despite being safe and well-tolerated, the lack of efficacy led to the company’s decision to also conclude the open-label extension study.

Edaravone is currently approved by Health Canada in two different formulations: RADICAVA® IV administered through intravenous (IV) infusions, and RADICAVA® Oral Suspension, an oral suspension taken by mouth or via a feeding tube. Both formulations are distributed by the pharmaceutical company Mitsubishi Tanabe Pharma Canada.

The ALS Society of Canada will work with clinicians and other key experts to better understand the implications of these results for Canadians living with ALS and remains committed to keeping the community updated as more information becomes available.