KalVista Pharmaceuticals Announces Early Completion of Enrollment in KONFIDENT-KID Pediatric HAE Trial

KalVista Pharmaceuticals announced the completion of enrollment in the open-label KONFIDENT-KID clinical trial of sebetralstat in pediatric patients between the ages of two and 11 with hereditary angioedema (HAE).

Ben Palleiko, CEO of KalVista, said: “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. 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.”

Originally 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.

(Source: KalVista)