KalVista Showcases Phase 3 KONFIDENT Trial Insights at AAAAI 2024

KalVista Pharmaceuticals, a clinical-stage pharmaceutical firm, has unveiled further data from its phase 3 KONFIDENT trial on sebetralstat at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Sebetralstat is an oral, small molecule protease inhibitor being developed for the on-demand treatment of Hereditary Angioedema (HAE) attacks.

The KONFIDENT trial's latest findings indicate that 94% of HAE attacks studied responded to a single dose of sebetralstat, meeting the primary endpoint. Detailed efficacy analyses revealed that the majority of attacks achieved symptom relief, a reduction in severity, and complete resolution without requiring a second dose. Specifically, 93.9% and 95.8% of attacks reached the beginning of symptom relief with 300 mg and 600 mg doses of sebetralstat, respectively. The corresponding figures for a reduction in attack severity were 90.9% and 95.9%. For complete attack resolution, the proportions were 91.9% and 84.8%.

The safety profile of sebetralstat was also scrutinized, with the data showing no significant difference between the safety profiles of one dose or two doses of the drug compared to placebo. Median times to symptom relief were shorter for attacks of higher initial severity, with times of 1.6 hours for 300 mg and 2.1 hours for 600 mg for moderate attacks, and 1.4 and 1.5 hours for severe attacks.

Marc Riedl, a professor at the University of California, San Diego, highlighted the importance of understanding the proportion of attacks that achieved the primary and key secondary endpoints with a single dose. He noted that the vast majority of attacks successfully met these endpoints with just one dose of sebetralstat.

Andrew Crockett, CEO of KalVista, stated that if approved, a single dose of sebetralstat 300 mg would likely be suitable for most HAE attacks, while the flexibility to adjust dosing according to the specifics of an attack is supported by the drug's safety and tolerability. He believes the additional data strengthens the case for sebetralstat to become the first oral on-demand treatment for the HAE community.

KalVista Pharmaceuticals is dedicated to developing oral, small molecule protease inhibitors for diseases with significant unmet needs. The company anticipates submitting a new drug application for sebetralstat to the U.S. FDA in the first half of 2024 and plans to seek approval in Europe and Japan later in the year. KalVista's oral Factor XIIa inhibitor program is also in development, aiming to provide further therapeutic advancements for HAE and other conditions.