KalVista Pharmaceuticals Presents Additional Phase 3 KONFIDENT Data at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting
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– Further analyses demonstrate efficacy across all levels of attack severity -
– Additional safety data reinforces flexibility of dosing -
The following late-breaking presentation occurred at AAAAI 2024:
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Sebetralstat for On-demand Treatment of Hereditary Angioedema Attacks: Results of the Double-blind, Placebo-controlled Phase 3 KONFIDENT Trial: Marc Riedl, Division of Rheumatology, Allergy and Immunology, University of California San Diego,
San Diego, California ,United States
Among the additional efficacy analyses from KONFIDENT presented during the poster session were the proportions of attacks reaching the primary (time to beginning of symptom relief) and key secondary endpoints (time to reduction in attack severity and time to complete attack resolution) without the use of a second dose. Proportions of attacks that reached the beginning of symptom relief without a second dose were
Data presented as a supplement also showed that the median time to all endpoints was shorter for attacks with higher initial severity, at both dose levels. Median times to beginning of symptom relief for moderate attacks were 1.6 hours for 300 mg and 2.1 hours for 600 mg, and for severe attacks the median times were 1.4 and 1.5 hours, respectively. Similarly, time to reduction in attack severity was also shorter for attacks that were rated moderate or severe at baseline, with median times of 5.0 and 3.3 hours, respectively, for moderate attacks and 1.3 and 1.4 hours, respectively, for severe attacks.
“Given the unrestricted use of a second dose of oral sebetralstat in KONFIDENT, it was important to understand the proportion of attacks that achieved the primary and key secondary endpoints without a second dose. What we observed was that the vast majority of attacks that successfully met the three endpoints did so with a single dose of sebetralstat,” said Marc A. Riedl, MD, Professor of Medicine and Clinical Director, US Hereditary Angioedema Association Center at the University of
“If approved, we believe that a single dose of sebetralstat 300 mg would appear to be appropriate for most HAE attacks. However, the ability to dose flexibly depending on the characteristics of a specific attack is supported by the safety and tolerability observed with repeated dosing at both 300 mg and 600 mg,” said Andrew Crockett, Chief Executive Officer of KalVista. “We believe that these additional efficacy and safety data only strengthen the case for sebetralstat to become the first, oral on-demand treatment available to the HAE community.”
Links to all posters and presentations can be found on the KalVista website under “Publications”.
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. KalVista disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024. The Company anticipates submitting a new drug application to the
For more information about KalVista, please visit www.kalvista.com.
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KalVista Pharmaceuticals, Inc.
Jarrod Aldom
Vice President, Corporate Communications
(201) 705-0254
jarrod.aldom@kalvista.com
Ryan Baker
Head, Investor Relations
(617) 771-5001
ryan.baker@kalvista.com
Source: KalVista Pharmaceuticals, Inc.