CAMBRIDGE, Mass. & SALISBURY, England - KalVista Pharmaceuticals, Inc. (NASDAQ: NASDAQ:KALV), a company specializing in the development of oral protease inhibitors, has revealed additional data from its phase 3 KONFIDENT trial for the drug sebetralstat.
The findings, presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting in Washington, DC, indicate that a single dose of sebetralstat may effectively treat hereditary angioedema (HAE) attacks.
The KONFIDENT trial showed that 93.9% to 95.8% of HAE attacks were relieved with just one dose of sebetralstat, without the need for a second dose. These results were consistent across both the 300 mg and 600 mg dosages. The trial also demonstrated that the drug's safety profile was comparable to placebo, whether administered in one or two doses.
Marc Riedl, MD, from the University of California San Diego, shared that the majority of HAE attacks reached primary and key secondary endpoints with a single dose of the medication. The endpoints included time to beginning of symptom relief, reduction in attack severity, and complete attack resolution.
The trial further highlighted that median times to relief were shorter for attacks with higher initial severity. For moderate attacks, the median time to symptom relief was 1.6 hours at 300 mg and 2.1 hours at 600 mg. For severe attacks, the median times were even shorter, at 1.4 and 1.5 hours, respectively.
KalVista's CEO, Andrew Crockett, expressed confidence in sebetralstat's potential as the first oral on-demand treatment for the HAE community, emphasizing the drug's efficacy and safety.
The company is preparing to submit a new drug application to the U.S. FDA for sebetralstat in the first half of 2024, with plans to seek approval in Europe and Japan later the same year. KalVista also has an oral Factor XIIa inhibitor program, which may offer additional treatment options for HAE and other diseases.
This article is based on a press release statement from KalVista Pharmaceuticals, Inc.
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