UCB's Phase IIb padsevonil ARISE study fails endpoints

Belgium’s largest drugmaker UCB (Euronext Brussels: UCB) today announced disappointing 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.

The company’s shares fell 3.04% to 73.30 euros, while the Euronext Brussels index rallied more than 4% by mid-morning.

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% 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.