–New data show effectiveness of sebetralstat in reducing anxiety during attacks; supports need for oral on-demand option to treat attacks earlier and more often–
–Patient perspectives spotlight the prevalence of anxiety when faced with administering injectable on-demand therapies–
KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), today announced that it presented data showing the effectiveness of sebetralstat in reducing anxiety among people experiencing hereditary angioedema (HAE) attacks at the HAEi Global Angioedema Forum (GAF) taking place in Copenhagen, Denmark, October 4 - 5, 2024. These data were generated in the KONFIDENT phase 3 clinical trial, for which the Company disclosed top line results in February 2024. Sebetralstat is a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of HAE attacks in adults and adolescents aged 12 years and older.
KONFIDENT was the first randomized controlled trial to assess the impact of an on-demand treatment on anxiety associated with HAE attacks. This prespecified exploratoryanalysis was presented by Dr. William R. Lumry, AARA Research Center, Dallas, TX, USA and investigated attack-associated anxiety (in the absence of injectable therapy) in the phase 3 KONFIDENT trial and the impact of sebetralstat on anxiety, compared with placebo. Participants self-reported anxiety using a Modified Generalized Anxiety Numeric Rating Scale. Overall, anxiety was reduced among patients treated with sebetralstat 300mg (P=0.004 and P=0.022, respectively) and 600mg (P=0.0008 and P=0.0012) versus placebo. For participants with moderate-to-extreme anxiety, change from baseline at 4 hours was −2.8 (−3.6, −1.9) for each sebetralstat group and −1.3 (−2.2, −0.4) for placebo and at 12 hours was −3.5 (−4.3, −2.6) with sebetralstat 300mg, −4.3 (−5.2, −3.5) with 600mg, and −1.7 (−2.6, −0.8) with placebo. Notably, anxiety reduction was correlated with earlier time to beginning of symptom relief.
