KalVista Pharmaceuticals, Inc. announces positive phase 1 data for an orally disintegrating tablet (ODT) formulation for its lead compound sebetralstat. Sebetralstat is currently being developed in the phase 3 KONFIDENT clinical trial as a potential on-demand treatment for HAE attacks.
“This new ODT formulation reflects a next step in our constant efforts to provide people with HAE more options to help them manage this disease,” says Andrew Crockett, CEO of KalVista. “Orally disintegrating tablets are a standard in other disease areas such as migraine and would be of benefit to many people with HAE, particularly younger patients. We expect this formulation to become available in the US and rest of the world following the initial launch of sebetralstat tablets.”
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.