Padsevonil in ARISE Phase IIb trial does not meet statistical significance for treatment of focal-onset seizures . UCB

UCB, a global biopharmaceutical company, announced top-line results from ARISE (NCT03373383), the first of two adequate and well-controlled studies, investigating the efficacy and safety of padsevonil for the treatment of observable focal-onset seizures in adults with drug-resistant epilepsy. This randomized, double-blind, placebo-controlled Phase IIb study did not reach statistical significance for either of the primary endpoints, change from Baseline in observable focal-onset seizure frequency and 75 percent responder rate for padsevonil compared with placebo over the 12-week maintenance period. Padsevonil was generally well-tolerated and its safety profile was consistent with that seen in earlier studies. ARISE is the first of two adequate and well-controlled studies which seek to investigate the safety and efficacy of UCB’s padsevonil in the treatment of focal-onset seizures in patients with highly treatment-resistant epilepsy. The impact of the ARISE results on the second, ongoing study, UCB0092 (DUET), is currently being evaluated.