KalVista Starts KONFIDENT-KID Trial for Hereditary Angioedema Treatment in Children

KalVista Pharmaceuticals, Inc., based in Cambridge, Massachusetts and Salisbury, England, has announced the initiation of the KONFIDENT-KID clinical trial. This open-label study will investigate sebetralstat, an innovative oral plasma kallikrein inhibitor, in young patients with hereditary angioedema (HAE). Approximately 24 children aged between 2 and 11 years from seven countries across North America, Europe, and Asia will participate in the trial. The study will gather safety, pharmacokinetic, and efficacy data over the period of one year, utilizing a specially designed pediatric oral disintegrating tablet (ODT) formulation of sebetralstat.

"We are pleased to announce that the KONFIDENT-KID trial has started earlier than previously anticipated," stated Ben Palleiko, the Chief Executive Officer of KalVista. Palleiko added that the early commencement of the trial signifies the strong enthusiasm among medical professionals, caregivers, and patient advocacy groups regarding sebetralstat's potential to treat pediatric HAE. Presently, the only approved on-demand treatment for this patient group requires intravenous administration, highlighting a significant unmet need in the management of pediatric HAE.

Should sebetralstat receive approval, it would become the first oral on-demand therapy available for children aged 2 to 11 years and the second on-demand therapy of any kind approved by the FDA for this age group.

KalVista Pharmaceuticals, Inc. is a global pharmaceutical company dedicated to the development and provision of oral medications for diseases with substantial unmet needs. In February 2024, the company reported positive phase 3 results from the KONFIDENT trial for sebetralstat as an oral, on-demand therapy. Following this, an NDA was submitted to the FDA in June 2024. KalVista anticipates receiving approval in the UK, Europe, and Japan later in 2024.