KalVista announces positive Phase 3 KONFIDENT results; sebetralstat meets all endpoints with rapid symptom relief

KalVista Pharmaceuticals, Inc.

Sebetralstat 300 mg achieved beginning of symptom relief in median 1.61 hours vs placebo 6.72 hours (p<0.0001).
Trial met all primary and key secondary endpoints; no treatment-related SAEs and no withdrawals due to AEs.
Treatment-related adverse event rates: 2.3% for 300 mg, 2.2% for 600 mg, 4.8% for placebo.
Plan to submit NDA to U.S. FDA in first half of 2024 and in EU and Japan later in 2024.
Largest HAE trial ever with 136 patients from 66 sites across 20 countries.

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