Press release
KalVista Initiates KONFIDENT-KID Trial for On-demand Treatment of Hereditary Angioedema Attacks with Sebetralstat in Children Aged 2 to 11
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced the initiation of the open-label
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":" CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced the initiation of the open-label KONFIDENT-KID clinical trial of sebetralstat, a novel, oral, plasma kallikrein inhibitor, in pediatric patients with hereditary angioedema (HAE). The trial will enroll approximately 24 children aged 2 to 11 years across seven countries in North America, Europe and Asia. KONFIDENT-KID will collect safety, pharmacokinetic, and efficacy data for each patient for up to one year and will feature a proprietary pediatric oral disintegrating tablet (ODT) formulation of sebetralstat.\n\n\n“We are pleased to announce that the KONFIDENT-KID trial has started earlier than previously anticipated,” said Ben Palleiko, Chief Executive Officer of KalVista. “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. 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.”\n\n\nIf approved, sebetralstat would be the first oral on-demand therapy in pediatric patients aged 2 – 11 years, and only the second FDA-approved on-demand therapy of any type in this population.\n\n\nFor more information on KONFIDENT-KID, please visit our listing on clinicaltrials.gov.\n\n\nAbout KalVista Pharmaceuticals, Inc.\n\n\nKalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need. KalVista disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024 and submitted an NDA with the FDA in June 2024. KalVista expects to file for approval in the UK, Europe, and Japan later in 2024.\n\n\nFor more information about KalVista, please visit www.kalvista.com.\n\n\nForward-Looking Statements\n\n\nThis press release contains \"forward-looking\" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: \"anticipate,\" \"intend,\" \"plan,\" \"goal,\" \"seek,\" \"believe,\" \"project,\" \"estimate,\" \"expect,\"...