Late-breaking results from the KONFIDENT phase 3 and open-label KONFIDENT-S extension trials were presented at the European Academy of Allergy and Clinical Immunology Congress 2024 and published in The New England Journal of Medicine.
The KONFIDENT trial met its primary endpoint, demonstrating the significant efficacy of sebetralstat in reducing the time to treatment and symptom relief of hereditary angioedema (HAE) attacks. Interim data from KONFIDENT-S showed a rapid onset of action, with a median time to treatment of 9 minutes and a median time to symptom relief of 1.3 hours for laryngeal attacks.
Analysis of key secondary endpoints revealed that sebetralstat was superior to placebo in reducing attack duration, hospitalizations, and the need for rescue medications. Subgroup analyses indicated that the treatment effect was consistent across different attack severities, locations, and use of long-term prophylaxis.
The safety profile of sebetralstat was comparable to that of the placebo. No patient withdrawals due to adverse events were observed, and no treatment-related serious adverse events were observed.
These results suggest that sebetralstat has the potential to improve the management of HAE attacks significantly. If approved, it would represent a major advance for people living with HAE and address the unmet need for an effective and convenient on-demand treatment option.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
