KalVista Pharmaceuticals KALV has initiated the KONFIDENT-S open label extension (OLE) study for its ongoing Phase 3 study of sebetralstat for the on-demand treatment of hereditary angioedema (HAE) attacks.
The KONFIDENT-S trial is designed to evaluate sebetralstat for the on-demand treatment of HAE attacks in adults living with HAE.
A sub-trial will accept participation by adolescents 12-17 years of age. The trial will also evaluate sebetralstat for use as a short-term prophylaxis treatment prior to medical procedures.
Andrew Crockett, Chief Executive Officer, commented: "Initiating this treatment extension represents another significant step in advancing sebetralstat towards an intended FDA filing. We can now provide participating patients with up to two additional years of therapy with what we expect will be the first oral, on-demand treatment for HAE attacks. 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."
The data readout from the KONFIDENT-S trial is anticipated in the second half of 2023 to support the planned NDA filing for sebetralstat in 2024.
Price Action : KalVista shares are trading around 10 percent at $16.48 on Tuesday during pre-market session.
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