KalVista presents additional Phase 3 KONFIDENT data at AAAAI meeting

KalVista Pharmaceuticals presented additional data on its phase 3 KONFIDENT trial for sebetralstat, including a more in-depth analysis of sebetralstat efficacy and safety at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting taking place in Washington, DC. The following late-breaking presentation occurred at AAAAI 2024: Sebetralstat for On-demand Treatment of Hereditary Angioedema Attacks: Results of the Double-blind, Placebo-controlled Phase 3 KONFIDENT Trial: Marc Riedl, Division of Rheumatology, Allergy and Immunology, University of California San Diego, San Diego, California, United States. Among the additional efficacy analyses from KONFIDENT presented during the poster session were the proportions of attacks reaching the primary and key secondary endpoints without the use of a second dose. Proportions of attacks that reached the beginning of symptom relief without a second dose were 93.9% and 95.8% with sebetralstat 300 mg and 600 mg, respectively, while the proportions of attacks reaching a reduction in severity without a second dose were 90.9% and 95.9% with sebetralstat 300 mg and 600 mg, respectively. These proportions were 91.9% and 84.8% for complete attack resolution. Additional safety analyses demonstrated that the safety profiles associated with one dose or two doses of sebetralstat 300 mg or 600 mg were comparable to placebo. Data presented as a supplement also showed that the median time to all endpoints was shorter for attacks with higher initial severity, at both dose levels. Median times to beginning of symptom relief for moderate attacks were 1.6 hours for 300 mg and 2.1 hours for 600 mg, and for severe attacks the median times were 1.4 and 1.5 hours, respectively. Similarly, time to reduction in attack severity was also shorter for attacks that were rated moderate or severe at baseline, with median times of 5.0 and 3.3 hours, respectively, for moderate attacks and 1.3 and 1.4 hours, respectively, for severe attacks.