KalVista submits additional MAAs for sebetralstat for treatment of HAE

KalVista announced Marketing Authorization Application submissions to the regulatory authorities in the United Kingdom, Switzerland, Australia, and Singapore for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema attacks in adults and adolescents aged 12 years and older. The four MAAs have been submitted via the Access Consortium framework for which KalVista has obtained a four-way work-sharing agreement by the Medicines and Healthcare product Regulatory Agency, Swissmedic, the Therapeutic Goods Administration and Health Sciences Authority. The Access Consortium is designed to maximize regulatory collaboration across countries and support a timely review process. The MAA submissions are supported by previously disclosed results, including data from the KONFIDENT phase 3 clinical trial and ongoing KONFIDENT-S open label extension trial. Sebetralstat met the primary endpoint for its phase 3 trial with both 300 mg and 600 mg formulations achieving the beginning of symptom relief significantly faster than placebo and was well-tolerated, with a safety profile similar to placebo. In KONFIDENT-S, sebetralstat has enabled patients to treat attacks early with a median time from attack onset to treatment of 9 minutes, demonstrated a consistent safety and efficacy profile with KONFIDENT, and included a median time to beginning of symptom relief for laryngeal attacks of 1.3 hours. KONFIDENT and KONFIDENT-S are the only clinical trials ever conducted in HAE that instruct participants to treat their attacks as early as possible, regardless of severity, in accordance with on-demand treatment guidelines. Early treatment of attacks, prior to progression, is a critical element in proper management of HAE, to minimize symptom burden. KalVista’s KONFIDENT-KID clinical trial, designed to evaluate the safety and efficacy of sebetralstat in a pediatric population aged 2-11 years, began dosing patients ahead of schedule in June 2024.