KalVista Pharmaceuticals presented new data at the 2024 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Boston, showcasing the potential of sebetralstat as an oral, on-demand treatment for hereditary angioedema (HAE). The presentations included analyses from the Phase 3 KONFIDENT trial and other studies, highlighting sebetralstat's efficacy in reducing symptom burden and treating laryngeal attacks.
Sebetralstat for Laryngeal HAE Attacks
A pooled analysis of data from the KONFIDENT and KONFIDENT-S trials demonstrated the effectiveness of sebetralstat in treating laryngeal HAE attacks. Laryngeal attacks are particularly dangerous due to the risk of airway obstruction. The data indicated that sebetralstat provided rapid relief for these severe episodes, offering a potential alternative to current intravenous or subcutaneous treatments.
KONFIDENT Trial: Symptom Burden Reduction
Data from the Phase 3 KONFIDENT trial revealed a substantial reduction in the overall symptom burden associated with HAE attacks in patients treated with sebetralstat. This suggests that sebetralstat not only addresses the immediate symptoms of an attack but also improves the overall quality of life for individuals living with HAE.
Indirect Treatment Comparison
An indirect treatment comparison between oral sebetralstat and intravenous rhC1-INH showed comparable efficacy in on-demand treatment of HAE. This finding supports sebetralstat as a viable oral option, potentially offering a more convenient administration route for patients.
Time to Treatment and Attack Duration
Further analysis of the KONFIDENT trial data explored the correlation between the time to treatment and the duration of HAE attacks. The results suggest that earlier administration of sebetralstat may lead to shorter attack durations, emphasizing the importance of timely intervention.
Sebetralstat, discovered and developed by KalVista, is an investigational oral plasma kallikrein inhibitor. It has received Fast Track and Orphan Drug Designations from the U.S. FDA and Orphan Drug Designation from the European Medicines Agency (EMA). KalVista's New Drug Application (NDA) for sebetralstat has been accepted by the FDA with a PDUFA goal date of June 17, 2025. The company has also submitted Marketing Authorisation Application (MAA) to the EMA and other regulatory bodies.
