KalVista Presents Latest Sebetralstat Findings at AAAAI 2025
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced the presentation of new data on sebetralstat at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) Joint Congress in San Diego, CA, held from February 28 to March 3, 2025. The data highlights sebetralstat’s effectiveness in treating laryngeal hereditary angioedema (HAE) attacks, as well as its potential benefits for adolescents with HAE.
The data, drawn from the KONFIDENT-S study, focused on the effectiveness of sebetralstat in treating laryngeal hereditary angioedema (HAE) attacks and in adolescents with HAE. KalVista’s CEO, Ben Palleiko, highlighted that the growing body of evidence from the study supports sebetralstat’s ability to provide rapid symptom relief when taken early, offering a significant improvement for vulnerable populations.
Rapid Treatment and Relief for Laryngeal HAE Attacks
One of the key presentations from the conference, titled “Effectiveness of Sebetralstat for the On-demand Treatment of Laryngeal Hereditary Angioedema Attacks: Interim Analysis from KONFIDENT-S,” was led by Jonathan Bernstein, MD, FAAAAI, a professor at the University of Cincinnati College of Medicine and partner at Bernstein Allergy Group. The study demonstrated that sebetralstat was effective in treating 32 laryngeal HAE attacks, with a median time to treatment of just 11.5 minutes after attack onset. Furthermore, the median time to the beginning of symptom relief was 1.27 hours, showing that most patients achieved symptom relief within 12 hours with a single dose of sebetralstat.
Dr. Bernstein emphasized the critical nature of treating laryngeal attacks promptly, as they can progress rapidly and lead to life-threatening complications such as asphyxiation. He noted that the average time to treatment for laryngeal attacks with injectable on-demand therapies was significantly longer, at about 2.5 hours. The KONFIDENT-S study, however, demonstrated that patients treated with sebetralstat experienced a median time to treatment of just under 12 minutes, followed by a median symptom relief time of 1 hour and 16 minutes. These findings suggest that sebetralstat could potentially offer faster relief compared to injectable treatments, which would be a critical advancement in managing such urgent attacks.
Sebetralstat for Adolescents with HAE
Another presentation, titled “On-demand Treatment of Hereditary Angioedema Attacks with Sebetralstat in Adolescents: Pooled Analysis from KONFIDENT and KONFIDENT-S,” was given by Professor Danny Cohn, head of the HAE clinic at Amsterdam University Medical Center. This analysis focused on 149 attacks treated with sebetralstat across both the KONFIDENT and KONFIDENT-S studies. The results showed that adolescents administered sebetralstat within a median of 4 minutes after attack onset, a significantly faster response compared to the 3-hour median and 5.2-hour mean delays observed in previous international survey data on injectable therapies.
Dr. Cohn highlighted the challenges faced by adolescents, who often experience longer delays in receiving treatment due to the requirement for healthcare professionals to administer injectable therapies. He noted that sebetralstat’s oral formulation could significantly ease these challenges by enabling adolescents to treat their attacks independently, without the need for intravenous or subcutaneous administration. Furthermore, the safety and efficacy of sebetralstat in adolescents were consistent with the results observed in adults, with no serious adverse events or adverse events leading to discontinuation.
The ability to take an oral medication could greatly reduce the anxiety and inconvenience often associated with injectable treatments, making sebetralstat a potentially transformative solution for adolescents with HAE.
Sebetralstat: A Potential Breakthrough in HAE Treatment
Sebetralstat is a novel, oral plasma kallikrein inhibitor designed to treat hereditary angioedema (HAE), a rare genetic disorder characterized by sudden and severe swelling attacks in various body parts. Currently, approved on-demand treatments for HAE require intravenous or subcutaneous administration, presenting challenges for many patients, particularly those with limited access to healthcare or those who experience anxiety with injections. If approved, sebetralstat would be the first oral on-demand treatment for HAE, with the potential to address significant unmet needs in the HAE community.
KalVista has filed regulatory applications for sebetralstat in individuals aged 12 and older and is conducting ongoing studies to explore its use in children as young as 2. The company’s regulatory submission for sebetralstat is under review by the U.S. FDA, with a Prescription Drug User Fee Act (PDUFA) goal date of June 17, 2025. Additionally, KalVista has submitted Marketing Authorization Applications to the European Medicines Agency (EMA) and other global regulatory authorities.
