– Late-breaking data from phase 3 KONFIDENT trial of sebetralstat published in NEJM and presented concurrently at the European Academy of Allergy and Clinical Immunology Congress 2024 –
– Interim data from KONFIDENT-S open-label trial show median time to treatment of 9 minutes and median time to beginning of symptom relief for laryngeal attacks 1.3 hours –
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that late-breaking data from the pivotal phase 3 KONFIDENT trial and open label KONFIDENT-S extension trial evaluating the efficacy and safety of sebetralstat were presented as late-breaking presentations at the European Academy of Allergy and Clinical Immunology Congress 2024. The results of KONFIDENT were simultaneously published in The New England Journal of Medicine.
“The phase 3 KONFIDENT results represent a major advance for people living with HAE and reinforce our commitment to addressing critical gaps in the current standard of care,” said Paul Audhya, MD, MBA, KalVista’s Chief Medical Officer. “The efficacy and safety data presented as a late-breaker at EAACI and simultaneously published in The New England Journal of Medicine support the potential of sebetralstat as the first new treatment approach for the on-demand treatment of HAE in more than a decade, and the first potential oral therapy for this indication.”
As presented and published, the KONFIDENT trial met its primary and key secondary endpoints and demonstrated a safety profile no different from placebo.
Phase 3 KONFIDENT Trial Results
- Median time from attack onset to treatment was 41 min (Q1, 6; Q3, 140) with 55.7% of participants treating in less than 1 hour
- 42.8% of attacks treated when still mild
Primary endpoint:
- Time to beginning of symptom relief was significantly faster than placebo (p12)
Key secondary endpoints:
- Significantly faster time to a reduction in attack severity from baseline compared to placebo (p=0.0036 for 300 mg sebetralstat, p=0.0032 for 600 mg sebetralstat)
- Significantly faster time to complete attack resolution compared to placebo (p=0.0022 for 300 mg sebetralstat, p