A phase 3 trial will be extending its duration to continue to test sebetralstat, a kallikrein inhibitor, as a potential treatment for patients with hereditary angioedema (HAE), according to a recent press release from KalVista Pharmaceuticals, Inc.
“Initiating this treatment extension represents another significant step in advancing sebetralstat towards an intended FDA filing following completion of the ongoing KONFIDENT phase 3 trial in the second half of 2023,” Andrew Crockett, chief executive officer of KalVista, said.
This clinical trial, named KONFIDENT-S, is an open-label extension of the phase 3 study that will continue to test sebetralstat as a treatment option for HAE for 2 more years. One of the main goals of this study is to determine the experimental therapy’s profile in the adolescent population.
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The ongoing research included adults. However, a subtrial will also include patients aged 12 to 17 years.
Read more about HAE therapies
“The data we collect in this trial will help us better understand the long-term safety profile of sebetralstat and may also inform future trials in younger patients,” Crockett said.
Sebetralstat is a plasma kallikrein inhibitor administered orally in tablet form. This investigational therapy is being studied as a potential treatment for on-demand acute HAE attacks in patients with a previous diagnosis of the disease.
Moreover, the clinical trial will evaluate the possible extended use of sebetralstat as prophylaxis prior to medical procedures in the near future.
The study aims to have the results of KONFIDENT-S available in 2023. Trial initiation follows the submission of toxicology studies to the US Food and Drug Administration (FDA). KalVista plans to file a New Drug Application (NDA) for sebetralstat in 2024.
Reference
KalVista Pharmaceuticals announces initiation of KONFIDENT-S open label extension study for sebetralstat in hereditary angioedema. News release. KalVista Pharmaceuticals, Inc; August 23, 2022.
