KalVista Pharmaceuticals presents additional phase-3 KONFIDENT data at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting

KalVista Pharmaceuticals today announced that it 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 (AAAAI) 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 (time to beginning of symptom relief) and key secondary endpoints (time to reduction in attack severity and time to complete attack resolution) 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.

Marc A Riedl, MD, Professor of Medicine and Clinical Director, US Hereditary Angioedema Association Center at the University of California, San Diego, said: “Given the unrestricted use of a second dose of oral sebetralstat in KONFIDENT, it was important to understand the proportion of attacks that achieved the primary and key secondary endpoints without a second dose. What we observed was that the vast majority of attacks that successfully met the three endpoints did so with a single dose of sebetralstat.”

Andrew Crockett, Chief Executive Officer of KalVista, said: “If approved, we believe that a single dose of sebetralstat 300 mg would appear to be appropriate for most HAE attacks. However, the ability to dose flexibly depending on the characteristics of a specific attack is supported by the safety and tolerability observed with repeated dosing at both 300 mg and 600 mg. We believe that these additional efficacy and safety data only strengthen the case for sebetralstat to become the first, oral on-demand treatment available to the HAE community.”

(Source: KalVista)