CAMBRIDGE, Mass. & SALISBURY, England – KalVista Pharmaceuticals, Inc. (NASDAQ: NASDAQ:) today announced successful results from its phase 3 KONFIDENT clinical trial of sebetralstat, a potential new oral treatment for hereditary angioedema (HAE). The trial, which included a broad range of patient demographics, met all primary and key secondary endpoints.
Patients treated with sebetralstat experienced the beginning of symptom relief in a median time of 1.61 hours, significantly faster than the placebo group, which reported a median time of 6.72 hours. The safety profile of sebetralstat was comparable to placebo, with no serious adverse events related to the treatment reported.
Andrew Crockett, CEO of KalVista, expressed optimism about sebetralstat’s potential as the first oral, on-demand therapy for HAE, citing the trial’s positive outcomes. The company anticipates submitting a new drug application to the U.S. FDA in the first half of 2024, with plans for submissions in the EU and Japan later in the year.
The KONFIDENT trial, the largest of its kind in HAE, enrolled 136 adult and adolescent patients from 66 clinical sites across 20 countries. The study’s design allowed patients to treat up to three attacks with two doses of sebetralstat.
Sebetralstat, a novel oral plasma kallikrein inhibitor, has received Fast Track and Orphan Drug designations from the U.S. FDA. The medication aims to provide a more convenient treatment option for HAE, a rare genetic disease characterized by painful swelling attacks, which currently requires intravenous or subcutaneous administration of on-demand treatments.
The phase 3 data will be presented at the American Academy of Allergy Asthma and Immunology (AAAAI) annual meeting on February 25, 2024. Today, KalVista will host a conference call at 8:30 a.m. ET to discuss the trial results.
This article is based on a press release statement from KalVista Pharmaceuticals, Inc.
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