New data presented by KalVista Pharmaceuticals on Thursday at the 2026 ISPOR Annual Meeting and the Eastern Allergy Conference reveals that current on-demand injectable treatment regimens impose a significant burden on children aged 2 to 11 with hereditary angioedema (HAE) and their caregivers.

Currently, the only FDA-approved on-demand treatment for this age group requires intravenous administration. However, an analysis of real-world claims data shows that while approximately two-thirds of these children are prescribed intravenous pdC1INH, the majority of treatments administered are actually off-label subcutaneous injections of icatibant. Alice Wang, Senior Director at KalVista, noted this suggests families and physicians may be seeking less invasive treatment options.

The data indicates a prominent unmet medical need. A caregiver survey found that nearly half of the children did not receive on-demand treatment during their most recent HAE attack. Among those who were treated, 93.7% experienced anxiety about using injectable therapy, with 68.8% reporting extreme anxiety. The primary reasons for avoiding treatment or experiencing treatment anxiety included fear of needles and the anticipation of burning, stinging, or pain from the injection. Seventy-five percent of the children experienced treatment side effects, most commonly injection site pain.

Ben Palleiko, CEO of KalVista, stated that these data underscore the significant unmet needs faced by children with HAE and their families, reinforcing the market demand for new, easy-to-use options that support early and consistent treatment.

Furthermore, caregivers also bear substantial stress. The survey revealed that during a child's most recent attack, 43% occurred outside the home, and 37% occurred without a caregiver present. Sixty-three percent of caregivers encountered difficulties when administering medication, and 90% felt anxious about whether to treat. The average time from attack onset to treatment was 2.8 hours, with only 31% of caregivers able to administer medication within one hour.

Notably, the vast majority of caregivers indicated that the factor most likely to improve a child's treatment experience would be having an oral therapy available.

Paul Audhya, Chief Medical Officer of KalVista, believes these challenges drive increased healthcare resource utilization, such as emergency department visits and home health services. He emphasized that these data reaffirm the value of an oral on-demand therapy.

KalVista is currently advancing its KONFIDENT-KID trial for the oral drug sebetralstat in children aged 2 to 11 and plans to submit a New Drug Application in the third quarter of 2026. The orally disintegrating tablet formulation of sebetralstat has demonstrated rapid onset and a favorable safety profile in clinical trials. If approved, it would become the first oral on-demand treatment for this age group.