KalVista launches sebetralstat trial in young children with HAE

Company asked FDA to approve treatment for older children in June

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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KalVista Pharmaceuticals has started a clinical trial to test the oral medication sebetralstat as an on-demand treatment for swelling attacks in children with hereditary angioedema (HAE), ages 2-11.

The launch of KONFIDENT-KID (NCT06467084) came just a few weeks after KalVista asked the U.S. Food and Drug Administration (FDA) to approve sebetralstat as an on-demand treatment of HAE attacks in patients ages 12 and older.

“We are pleased to announce that the KONFIDENT-KID trial has started earlier than previously anticipated,” Ben Palleiko, CEO of KalVista, said in a company press release. “This timeline reflects the high level of excitement among physicians, caregivers, and our patient advocacy partners regarding the potential of sebetralstat to treat children with HAE.”

In HAE, the excessive production of the signaling molecule bradykinin drives the swelling attacks. Sebetralstat, formerly KVD900, is designed to inhibit kallikrein, an enzyme involved in producing bradykinin. By lowering bradkyinin production, the experimental therapy should resolve HAE-related swelling.

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KalVista will seek global approvals of sebetralstat for HAE this year

First oral, on-demand treatment

In the Phase 3 KONFIDENT clinical trial (NCT05259917) and the KONFIDENT-S extension study (NCT05505916), which tested sebetralstat in HAE patients ages 12 and older, most participants given sebetralstat began seeing symptom relief in less than two hours.

While other on-demand treatments are available to manage HAE attacks, they’re all given by injection. Sebetralstat is poised to be the first oral on-demand treatment for adults and adolescents with HAE. If the results from the new trial are positive, KONFIDENT-KID could support applications for sebetralstat’s approval in younger children.

“Currently, the only approved on-demand treatment for this population is administered intravenously, making this a critical area of unmet need for people living with HAE,” Palleiko said.

KONFIDENT-KID will be an open-label study. All the children who participate in it will be treated with one of three doses (75, 150, or 300 mg) of sebetralstat, given as an oral disintegrating tablets.

The study’s main goal will be to test the therapy’s safety, which will be assessed by evaluating the proportion of children having side effects throughout the trial, which will last up to a year. Secondary goals include assessing how long after treatment patients begin having relief from symptoms.

The trial is expected to recruit about 24 children with HAE types 1 or 2 at sites across North America, Europe, and Asia. Recruitment hasn’t begun yet.