New data on sebeltralstat highlights medicine’s potential in HAE management

The findings of a series of studies on sebeltralstat, which is currently undergoing testing amongst HAE patients, were announced by the pharmaceutical company KalVista and shared with HAEi. The company announced:

  • New sebetralstat findings related to time to end of progression of hereditary angioedema (HAE) attacks
  • The effectiveness of treatment of attacks considered the most debilitating by patients, mucosal attacks, and attacks that have progressed in severity after a treatment delay.

These data were presented at two congresses taking place concurrently: the 14th C1-inhibitor Deficiency & Angioedema Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida, from 29 May – 1 June 2025.

One of the healthcare professionals conducting these trials, Dr William Lumry MD, Clinical Professor of Internal Medicine at the University of Texas Southwestern Medical School in Dallas and Director at Allergy and Asthma Research Associates, Dallas, Texas, United States, said: “Stopping the progression of an HAE attack as early as possible is paramount to mitigating its impact on patients. In both the KONFIDENT and KONFIDENT-S studies, sebetralstat halted attack progression in a median time of 19.8 minutes. As prior data have demonstrated near-complete plasma kallikrein inhibition 15 minutes after treatment, this analysis reveals that attacks are halted minutes after absorption. The consistency of findings across the KONFIDENT and KONFIDENT-S trials underscores the potential of sebetralstat as an effective and rapid-acting on-demand treatment for HAE attacks.”

Another of the clinical triallists, Henriette Farkas, M.D., PhD, DSc, Professor of Allergology and Clinical Immunology at Semmelweis University and Head of the Hungarian Angioedema Center of Reference and Excellence, Budapest, Hungary, said: “Mucosal HAE attacks, particularly those affecting the larynx, are a significant concern for patients and clinicians due to the risk of rapid progression and severe consequences, including the possibility of asphyxiation if left untreated. These interim data from KONFIDENT-S demonstrate that sebetralstat provided rapid relief and resolution of both abdominal and laryngeal attacks with a favorable safety profile. Patients were able to self-administer sebetralstat very early in the course of an attack, when most attacks were still mild or moderate in severity.”

Paul Audhya MD MBA, Chief Medical Officer of KalVista, said: “Even in real-world, high-stakes scenarios—be it mucosal attacks or severe attacks due to delayed treatment—sebetralstat consistently delivered rapid and reliable relief. The uniformity of these results, paired with an oral tablet formulation, solidifies our belief that sebetralstat can empower patients to act swiftly and recover quickly. We remain committed to bringing this innovative therapy to the HAE community as quickly as possible.”

(Source: KalVista)