KalVista Pharma Hits Targeted Number of Patients in Sebetralstat Trial
By Chris Wack
KalVista Pharmaceuticals said Monday it has hit a milestone in its clinical trial for its lead program sebetralstat, in development as a potential oral on-demand therapy for hereditary angioedema.
The clinical-stage pharmaceutical company has achieved the targeted number of on-treatment attacks required to complete the phase 3 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.
KalVista expects topline data in early 2024, remaining on track for a New Drug Application submission to the U.S. Food and Drug Administration in the first half of 2024. The company also expects to file for approval in the European Union and Japan later in 2024.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
November 13, 2023 06:58 ET (11:58 GMT)
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