Positive phase 1 data for orally disintegrating tablet formulation of sebetralstat for use in hereditary angioedema
KalVista recently completed a clinical trial to investigate the pharmacokinetics of the ODT The phase 1, open-label, randomized, single-dose, 3-way crossover trial enrolled 36 healthy adult volunteers to compare the pharmacokinetics (PK) of sebetralstat following administration of ODT and the current film-coated tablets in healthy adult volunteers
Data from the study showed that the ODT tablet formulation has a similar PK profile to the film-coated version currently in development. Based upon these results, KalVista intends to continue to develop the formulation with the intention to make it available as soon as possible after the sebetralstat anticipated launch in the US. KalVista currently expects that data from the KONFIDENT study using the film-coated tablets will be available in the second half of 2023, to support a planned NDA filing in the first half of 2024.
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