Ulixacaltamide

Essential3 Study 1 randomized 473 participants. At Day 56, mADL11 changed by -4.3 with ulixacaltamide and -1.7 with placebo in the mITT populations of 199 and 233 participants, respectively; the between-group difference was -2.57 points (95% CI, -3.62 to -1.53). Study 2 enrolled 238 participants and randomized 80 responders to continued treatment or placebo; 55% and 33%, respectively, maintained response. Drug-related adverse events led to discontinuation in 63 of 233 ulixacaltamide recipients (27.0%) versus 4 of 234 placebo recipients (1.7%) in Study 1, and 65 of 231 ulixacaltamide recipients (28.1%) in Study 2. Essential1 did not meet its primary endpoint (p=0.126); its TETRAS-ADL secondary result was nominally significant (p=0.026).