The trial was initially structured for enrolling 24 subjects, but has since been expanded due to high demand. Credit: Pixel-Shot / Shutterstock.

US-based biopharmaceutical company KalVista Pharmaceuticals has finished enrolling subjects in its KONFIDENT-KID trial of sebetralstat, an oral plasma kallikrein inhibitor designed to treat hereditary angioedema (HAE) in children.

This open-label trial is intended for HAE patients who are aged between two and 11 years.

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Initially structured for enrolling 24 subjects, the trial has expanded due to high demand and will now involve nearly 36 children across seven countries in Asia, Europe and North America.

The study aims to gather pharmacokinetic, efficacy and safety data over a 12-month period using a paediatric oral disintegrating tablet formulation of the therapy.

KalVista Pharmaceuticals CEO Ben Palleiko said: “We’re proud to share that we achieved target enrolment in our KONFIDENT-KID trial a full year ahead of schedule and expanded the trial size due to overwhelming interest.

“Even with this larger trial size, we anticipate that initial results will be shared later this year, with a supplemental new drug application expected to be filed by mid-2026.”

Sebetralstat is currently being reviewed by the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act goal date set for 17 June this year.

The approval would make it the first oral on-demand therapy for children aged two to 11 years, as well as the second on-demand therapy of any type approved for that age group.

KalVista said that sebetralstat could become a foundational therapy for managing HAE worldwide if approved.

The company has submitted marketing authorisation applications for the therapy to the European Medicines Agency and other international regulatory bodies.

HAE is a rare genetic condition characterised by a deficiency or dysfunction in the C1 esterase inhibitor protein, leading to uncontrolled activation of the kallikrein-kinin system and resulting in painful, potentially life-threatening swelling attacks.

All currently approved on-demand treatment options for the condition are administered either intravenously or subcutaneously.