KalVista Pharmaceuticals Presents Data at Eastern Allergy Conference 2024 and the Japanese Dermatological Association 2024
KalVista Pharmaceuticals 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.
Ben Palleiko, CEO of KalVista Pharmaceuticals: “We have observed exceptional consistency of results across subgroups in the KONFIDENT trial including attack severity, location, treatment paradigm (with or without long-term prophylaxis) and geography. This data further highlights that patients on LTP generally continue to have attacks, and that those attacks have similar impact as on-demand only users, showing the continued unmet need although it is not generally recognized. In parallel, claims data also highlight that on-demand prescription volumes have remained stable despite the introduction of subcutaneous and oral long-term prophylaxis options. Sebetralstat has the potential to transform the management of HAE.”
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 PC, 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 PC, 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 PC, 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 <1 hour were associated with a lower impact on QoL
- Real-world Impact of Treated Hereditary Angioedema Attacks on Patients’ Employment and Work Productivity: Maeve O’Connor, Allergy, Asthma, & Immunology Relief of Charlotte, Charlotte, NC, United States. (Poster presentation)
- HAE attacks among patients receiving non-androgen LTP and those receiving on-demand treatment only similarly impacted the work lives of employed patients resulting in impairments in their ability to work, substantial absenteeism, reduced productivity, and presenteeism among those who were able to work
- Burden of the Untreated Attacks and its Impact on Social, Mental and Physical Health: Maeve O’Connor, Allergy, Asthma, & Immunology Relief of Charlotte, Charlotte, NC, United States. (Poster presentation)
- Patients, including those taking LTP, reported that untreated HAE attacks often progressed in severity, migrated to other locations, and were associated with social isolation and impact on physical/mental health
- 70% of patients indicated that their last untreated attack had an impact on their energy levels; 55% and 22% of LTP and on-demand only patients, respectively, felt reluctant to go out in public
The following presentation occurred at the Annual Meeting of the JDA 2024:
- Sebetralstat KONFIDENT Is the First Phase 3 On-demand HAE Trial to Include Japanese Sites: Daisuke Honda, Chiba University Graduate School of Medicine, Chiba, Japan. (Poster presentation)
- Despite the relatively small number of attacks that were treated in the subgroup of Japanese KONFIDENT participants, primary endpoint results were consistent with those observed in the overall trial population
- Among Japanese participants, sebetralstat was well tolerated with no treatment-related TEAEs, no serious or severe TEAEs, and no TEAEs leading to study discontinuation
(Source: KalVista)