– US subgroup in the phase 3 KONFIDENT trial demonstrates median time to treatment of 38 minutes and time to beginning of symptom relief 1.3 hours –
– Despite growing use of long-term prophylaxis therapies in the US on-demand treatment prescription volumes stay stable and non-prescription healthcare costs for management of HAE remain substantial –
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that it presented the US subgroup analysis from the sebetralstat phase 3 KONFIDENT trial and real-world claims and patient survey data at the Eastern Allergy Conference (EAC) 2024, as well as the Japanese subgroup from KONFIDENT at the 123rd Annual Meeting of the Japanese Dermatological Association (JDA) 2024. KONFIDENT is the first pivotal phase 3 trial to include Japanese sites in an HAE development program.
The following presentations occurred at EAC 2024:
-
Sebetralstat for On-demand Treatment of Hereditary Angioedema Attacks: US Subgroup Analysis from the Double-blind, Placebo-controlled Phase 3 KONFIDENT Trial: Daniel Soteres, Asthma & Allergy Associates P.C., Colorado Springs, Colorado, United States. (Poster presentation)
- Median time from attack onset to administration was 38 minutes (IQR 5-124) for the US subgroup (78 attacks), which compares favorably to the median time to treatment of 41 minutes (IQR 6-140) in the overall trial population
- Median time to beginning of symptom relief for 300 mg in the US subgroup was 1.28 hours (IQR 0.77-3.12), which also compares favorably to the 300 mg median time to beginning of symptom relief of 1.61 hours (IQR 0.78-7.04) for the overall trial population
-
Trends in volume of on-demand hereditary angioedema treatments in the US: A retrospective analysis of a large multi-payer claims database: Daniel Soteres, Asthma & Allergy Associates P.C., Colorado Springs, Colorado, United States. (Poster presentation)
- Despite the advent of multiple non-androgen LTPs since 2017, the overall trend in the total number of claims reimbursed and quantity dispensed for on-demand treatments has remained stable in the US
- Average year-over-year variability in the total number of on-demand syringes and vials dispensed per quarter has remained within 3% and 10%, respectively, of baseline from Q3 2018 – Q3 2023
-
Healthcare Costs Among Commercially Insured Patients with Hereditary Angioedema Managed with Long-term Prophylaxis: a Retrospective US Claims Database Analysis: Daniel Soteres, Asthma & Allergy Associates P.C., Colorado Springs, Colorado, United States. (Poster presentation)
- Claims database analysis revealed that HAE-related non-pharmacy resource utilization costs among patients receiving non-androgen LTP were substantial, averaging >$641,000 in HAE healthcare costs per patient per year
- Approximately one-third of patients receiving non-androgen LTP had ≥1 HAE-related ER visits during follow-up (33%), and nearly one-quarter (22%) had ≥1 HAE-related home health visit
-
Real-World Impact of Treated Hereditary Angioedema Attacks on Patients’ Quality of Life: Maeve O’Connor, Allergy, Asthma, & Immunology Relief of Charlotte, Charlotte, NC, United States. (Poster presentation)
- Attacks occurring among patients receiving non-androgen LTP and those receiving on-demand treatment only similarly impact physical and social quality of life (QoL)
- Attacks treated in