Press release
KalVista Pharmaceuticals Announces Initiation of KONFIDENT-S Open Label Extension Study for Sebetralstat in Hereditary Angioedema
- NDA-supporting study extension provides additional two years of treatment with sebetralstat to assess long-term safety and tolerability in HAE patients - -
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\n- NDA-supporting study extension provides additional two years of treatment with sebetralstat to assess long-term safety and tolerability in HAE patients -\n\n- Subtrial will assess sebetralstat profile in adolescent patients -\n\n CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced the initiation of the KONFIDENT-S open label extension (OLE) study for its ongoing Phase 3 KONFIDENT study of sebetralstat for the on-demand treatment of hereditary angioedema (HAE) attacks.\n\n“Initiating this treatment extension represents another significant step in advancing sebetralstat towards an intended FDA filing following completion of the ongoing KONFIDENT Phase 3 trial in the second half of 2023,” said Andrew Crockett, Chief Executive Officer of KalVista. “We can now provide participating patients with up to two additional years of therapy with what we expect will be the first oral, on-demand treatment for HAE attacks. The data we collect in this trial will help us better understand the long-term safety profile of sebetralstat and may also inform future trials in younger patients.”\n\nThe KONFIDENT-S trial is evaluating sebetralstat, an oral plasma kallikrein inhibitor designed for the on-demand treatment of HAE attacks in adults living with HAE, and a subtrial will allow participation by adolescents 12-17 years of age. The trial will also evaluate sebetralstat for use as a short-term prophylaxis treatment prior to medical procedures.\n\nData from the KONFIDENT-S trial will be available in the second half of 2023 to support the Company’s planned NDA filing for sebetralstat in 2024. Initiation of this OLE study follows submission to the FDA of pivotal toxicology studies intended to support the eventual NDA filing.\n\nFor more information on the open-label extension study, please refer to NCT# NCT05505916.\n\nAbout KalVista Pharmaceuticals, Inc.\n\nKalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. KalVista has developed a proprietary portfolio of novel, small molecule plasma...