Business
KalVista Pharmaceuticals Announces Positive Interim Phase 3 Data From KONFIDENT-KID Trial of EKTERLY® (sebetralstat) for Children Aged 2-11 Years at the 2026 Global Angioedema Leadership Conference
Interim data show sebetralstat enables early, effective treatment of hereditary angioedema (HAE) attacks in children with favorable safety and tolerability
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\nInterim data show sebetralstat enables early, effective treatment of hereditary angioedema (HAE) attacks in children with favorable safety and tolerability\n\n\n FRAMINGHAM, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced new interim results from its KONFIDENT-KID clinical trial evaluating EKTERLY® (sebetralstat) for the on-demand treatment of hereditary angioedema (HAE) attacks in children ages 2-11 presented at the 2026 Global Angioedema Leadership Conference. KONFIDENT-KID is the largest pediatric trial ever conducted in HAE. It features a proprietary oral disintegrating tablet (ODT) formulation of sebetralstat in a population that currently relies on burdensome injectable treatments. The study was designed to enable compliance with treatment guidelines, consistent with the recently published “International Guideline on the Diagnosis and Management of Pediatric Patients with Hereditary Angioedema,” which recommends ensuring on-demand treatment is available anytime, anywhere and prioritizes early intervention and rapid self-administration, regardless of attack severity or location.\n\n\nOn-demand Oral Sebetralstat for Hereditary Angioedema Attacks in Children Aged 2-11: Interim Analysis of KONFIDENT-KID was presented by Emel Aygören-Pürsün, MD, University Hospital Frankfurt.\n\n\n\nAmong 172 HAE attacks in 33 pediatric participants treated using weight-based dosing of sebetralstat in a proprietary oral disintegrating tablet (ODT) formulation as of December 15, 2025:\n\n\nMean 0.7 attacks treated per patient per month\n\n\n\nMedian time to treatment of 25 minutes with 67% of attacks treated within the first hour; 88.9% were mild or moderate in severity\n\n\n\nMedian times to symptom relief and complete resolution (150 mg dose group, largest cohort) were 1.5 hours and 12 hours respectively\n\n\n\n\n\n\nSebetralstat was well tolerated with no serious or treatment-related adverse events, and no reports of difficulty swallowing.\n\n\n\n“Managing HAE attacks in children remains particularly challenging, as currently available on-demand treatments rely on injections or intravenous infusions that can be painful, anxiety-inducing, and difficult to administer promptly at symptom onset,” said Dr. Aygören-Pürsün. “These barriers can contribute to treatment delays or avoidance,...