Press release
KalVista Pharmaceuticals Announces Early Completion of Enrollment in KONFIDENT-KID Pediatric HAE Trial
Initial target enrollment surpassed in fewer than seven months; trial expanded due to high demand First data presentation expected before year-end; sNDA
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\nInitial target enrollment surpassed in fewer than seven months; trial expanded due to high demand\n\nFirst data presentation expected before year-end; sNDA submission by mid-2026\n\n CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced the completion of enrollment in the open-label KONFIDENT-KID clinical trial of sebetralstat, an investigational, novel, oral plasma kallikrein inhibitor, in pediatric patients between the ages of two and 11 with hereditary angioedema (HAE).\n\n“We're proud to share that we achieved target enrollment in our KONFIDENT-KID trial a full year ahead of schedule and expanded the trial size due to overwhelming interest,” said Ben Palleiko, CEO of KalVista. \"The high level of participation from families living with HAE underscores the significant need for an oral treatment option for this population. Even with this larger trial size, we anticipate that initial results will be shared later this year, with an sNDA expected to be filed by mid-2026.”\n\nOriginally designed to enroll 24 pediatric patients, the trial was met with high demand and will ultimately include approximately 36 patients between the ages of two and 11 across seven countries in North America, Europe, and Asia. KONFIDENT-KID will collect safety, pharmacokinetic, and efficacy data for up to one year and features a proprietary pediatric oral disintegrating tablet (ODT) formulation of sebetralstat.\n\nCurrently, the only on-demand treatment for HAE patients of this age range approved in the U.S. is administered intravenously, highlighting a critical need for new therapeutic options. If approved, sebetralstat would be the first oral on-demand therapy for pediatric patients aged two to 11 years and only the second FDA-approved on-demand therapy of any type in this population.\n\nFor more information about KONFIDENT-KID, please visit clinicaltrials.gov.\n\nAbout Sebetralstat\n\nSebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older and are investigating its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundati...