KalVista reaches patient milestone in Phase 3 KONFIDENT trial

KalVista Pharmaceuticals provided clinical trial and regulatory updates for its lead program sebetralstat, in development as a potential oral on-demand therapy for hereditary angioedema. KalVista 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. Topline data readout is expected in early 2024, remaining on track for a NDA submission to the FDA in the first half of 2024. The company also expects to file for approval in the European Union and Japan later in 2024. In 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.