KalVista Announces Positive Interim Data for Pediatric HAE Treatment

KONFIDENT-KID trial shows oral sebetralstat enables early, effective treatment of hereditary angioedema attacks in children

Mar. 30, 2026 at 11:53am

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KalVista Pharmaceuticals announced positive 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. The study found that children and caregivers were able to treat attacks early and achieve rapid symptom relief with sebetralstat, an oral on-demand option that has the potential to transform the treatment experience for children and families.

Why it matters

Managing HAE attacks in children remains challenging, as currently available on-demand treatments rely on injections or infusions that can be painful, anxiety-inducing, and difficult to administer promptly. An effective oral on-demand option like sebetralstat could enable early treatment and reduce the burden for children and their caregivers.

The details

The KONFIDENT-KID trial is the largest pediatric trial ever conducted in HAE. It features a proprietary oral disintegrating tablet (ODT) formulation of sebetralstat, which was designed to enable compliance with treatment guidelines that prioritize early intervention and rapid self-administration. The interim data show sebetralstat enabled children and caregivers to treat attacks early and achieve rapid symptom relief, with a favorable safety profile.

  • KalVista completed enrollment in the Phase 3 KONFIDENT-KID trial a full year ahead of schedule.
  • KalVista expects to file a new drug application in the US in the third quarter of 2026 with a launch anticipated in 2027.

The players

Emel Aygören-Pürsün, MD

University Hospital Frankfurt, presenter of the KONFIDENT-KID data.

Ben Palleiko

Chief Executive Officer of KalVista Pharmaceuticals.

EKTERLY (sebetralstat)

A novel plasma kallikrein inhibitor approved for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older.

KalVista Pharmaceuticals, Inc.

A global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs.

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What they’re saying

“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. These barriers can contribute to treatment delays or avoidance, which may worsen outcomes. The KONFIDENT-KID data demonstrate that children and caregivers were able to treat attacks early and achieve rapid symptom relief with sebetralstat.”

— Emel Aygören-Pürsün, MD, University Hospital Frankfurt

“Each update from KONFIDENT-KID continues to build compelling evidence that sebetralstat has the potential to transform the treatment paradigm for children living with HAE. The rapid pace of enrollment and high attack treatment rate may signal a meaningful shift in treatment behavior with an oral on-demand option.”

— Ben Palleiko, Chief Executive Officer of KalVista Pharmaceuticals

What’s next

KalVista expects to file a new drug application in the US in the third quarter of 2026 with a launch anticipated in 2027.

The takeaway

The KONFIDENT-KID trial results demonstrate that an effective oral on-demand treatment option like sebetralstat has the potential to significantly reduce the burden of HAE for children and their families by enabling early, convenient treatment of attacks. This could represent a major advancement in the management of this rare and debilitating disease.