Press release
KalVista Pharmaceuticals Announces Phase 3 KONFIDENT Trial Milestone Achieved
- Study completion activities underway; topline data expected early 2024 – - Largest-ever HAE clinical trial meets on-treatment attack target – - NDA
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\n- Study completion activities underway; topline data expected early 2024 –\n\n\n- Largest-ever HAE clinical trial meets on-treatment attack target –\n\n\n- NDA submission remains on track for first half 2024 –\n\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 provided clinical trial and regulatory updates for its lead program sebetralstat, in development as a potential oral on-demand therapy for hereditary angioedema (HAE).\n\n\nClinical Trial and Regulatory Updates:\n\n\n\nKalVista has achieved the targeted number of on-treatment attacks required to complete the phase 3 KONFIDENT trial. The trial is a cross-over study in which patients are intended to treat a total of three attacks: one each with 300 mg sebetralstat, 600 mg sebetralstat and placebo, given in a randomized sequence.\n\n\n\nTopline data readout is expected in early 2024, remaining on track for a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the first half of 2024. The Company also expects to file for approval in the European Union and Japan later in 2024.\n\n\n\nKONFIDENT randomized a total of 136 participants from 66 sites across 20 countries, making it the largest clinical trial ever conducted in HAE based on number of subjects. The enrolled patients are representative of the global HAE population and include participants 12 years of age and above, with or without long-term prophylaxis, with all attack locations eligible for treatment, including the larynx.\n\n\n\nIn addition, the KONFIDENT-S open label extension study continues to enroll, and the Company expects it will provide a robust safety database to support the planned NDA filing. In total, more than 600 attacks have been treated across KONFIDENT and KONFIDENT-S, and KONFIDENT-S includes numerous patients who have taken multiple doses for treatment as well as short-term prophylaxis.\n\n\n\n“We are excited to have reached the number of on-treatment attacks required for completion of KONFIDENT,” said Andrew Crockett, Chief Executive Officer of KalVista. “We have now initiated study closeout activities which enables topline data readout in early 2024, main...