First Patient Enrolled for Oral Edaravone Amyotrophic Lateral Sclerosis Treatment

The amyotrophic lateral sclerosis (ALS) Deceleration with ORal Edaravone (ADORE) phase 3 clinical trial for an oral formulation of edaravone (FNP122; Ferrer, Barcelona, Spain) has enrolled the first participant. The trial is being conducted in Europe and will enroll approximately 300 participants. 

Previously known as TW001, in a phase 1 randomized cross-over comparison study, bioavailability of a single 140 mg oral dose exceeded the bioavailability of a 60 mg intravenous infusion dose. Oral treatment was well-tolerated, and no safety concerns arose. 

The ADORE phase 3 clinical trial is being conducted with the support of TRICALS, the largest European research initiative to find a cure for ALS. Prof. Leonard H. van den Berg, chair of TRICALS, professor of Neurology at the University Medical Centre Utrecht, The Netherlands, and principal investigator of the study explained, “The TRICALS consortium is proud to collaborate with Ferrer, since this is an important study, and we look forward to offering further support throughout the course of the trial. We hope oral edaravone will yield a positive outcome and be beneficial for people diagnosed with ALS, as more effective treatment is available”.

Edaravone is an antioxidant and free radical scavenger that has been shown to reduce excess oxidative stress and cell death, playing an important role in the pathology of ALS.