News
New Data on Sebetralstat for HAE
KalVista Pharmaceuticals, Inc. announced the presentation of novel sebetralstat data related to laryngeal hereditary angioedema (HAE) attacks and adolescents with HAE at the American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) 2025 Joint Congress taking place in San Diego, CA from February 28–March 3, 2025
- “The growing body of data from the KONFIDENT-S study consistently demonstrate that sebetralstat enabled early treatment and fast symptom relief from HAE attacks, regardless of age, attack location, or severity,” said Ben Palleiko, CEO of KalVista. “This is especially critical for vulnerable populations, such as those experiencing laryngeal attacks or adolescents whose only approved options are injectable on-demand treatments. Sebetralstat, if approved, would be the first oral on-demand treatment for HAE attacks, with the potential to address some of the most significant unmet needs in HAE and become the foundational therapy for HAE management."
- Effectiveness of Sebetralstat for the On-demand Treatment of Laryngeal Hereditary Angioedema Attacks: Interim Analysis from KONFIDENT-S was presented by Jonathan Bernstein, MD, FAAAAI, Professor of Clinical Medicine in the Department of Internal Medicine, Division of Allergy and Immunology at the University of Cincinnati College of Medicine; Partner at Bernstein Allergy Group and Clinical Research Center.
- i. 32 laryngeal attacks were treated with sebetralstat (September 14, 2024 cutoff)
- ii. Median time to treatment with sebetralstat: 11.5 minutes after attack onset
- iii. Median time to beginning of symptom relief: 1.27 hours
- iv. 96% of those achieving beginning of symptom relief within 12 hours did so with a single dose
- v . No reports of difficulty swallowing film-coated tablet
- “Laryngeal attacks are often unpredictable and can progress rapidly, potentially leading to asphyxiation,” said Dr. Bernstein. “Any attack involving the larynx must be considered a medical emergency and treated as quickly as possible after onset before symptoms worsen. Despite this, recent U.S. survey data showed the mean time to treatment for laryngeal attacks with injectable on-demand therapies was 2.5 hours. Patients in the KONFIDENT-S study treated their attacks with sebetralstat, with a median time to treatment of just under 12 minutes, followed by symptom relief with a median time of 1 hour and 16 minutes. These results show that in the time it takes many patients to decide whether to treat, prepare and administer an injectable on-demand treatment, most patients in KONFIDENT-S were already experiencing symptom relief. If approved, sebetralstat could represent a therapeutic advance over injectables.”
- On-demand Treatment of Hereditary Angioedema Attacks with Sebetralstat In Adolescents: Pooled Analysis From KONFIDENT And KONFIDENT-S was presented by Professor Danny Cohn, Head of the HAE clinic at Amsterdam University Medical Center (UMC), University of Amsterdam, Netherlands.
- i. 149 attacks were treated with sebetralstat across KONFIDENT/KONFIDENT-S (September 14, 2024 cutoff)
- ii. Median time from attack onset to treatment: 4 minutes
- iii. Safety and efficacy consistent with adults; no serious adverse events or adverse events leading to discontinuation.
- "Adolescents face considerable challenges in treating their HAE attacks, with substantially longer delays to treatment than adults. This challenge is compounded in the U.S., where the only approved treatments options require either intravenous administration or subcutaneous administration by an HCP,” said Dr. Cohn. “The pooled data from the KONFIDENT and KONFIDENT-S studies show that adolescents administered sebetralstat in a median of 4 minutes after attack onset, which compares favorably to a median of 3 hours and mean of 5.2 hours based on international survey data that was presented at AAAAI by Dr. Paula Busse titled, ‘Burden of Injectable On-Demand Treatment for Hereditary Angioedema Attacks in Adolescents’. Importantly, the safety and effectiveness of sebetralstat were consistent with what was observed in adults. The portability and ease of administration of sebetralstat, along with the elimination of injection-site reactions and associated anxiety, has the potential to bring transformative change to this underserved patient population."
Condition: Hereditary Angio-Oedema
Type: drug
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