KalVista Pharmaceuticals has announced positive phase 1 data for an orally disintegrating tablet formulation of sebetralstat, a small molecule protease inhibitor currently being investigated in a phase 3 trial for on-demand treatment of hereditary angioedema (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,” said Andrew Crockett, chief executive officer 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.”
The orally disintegrating tablet tablet formulation of sebetralstat showed a similar pharmacokinetic profile to the version currently in development (ie, a film-coated version) according to data from the phase 1, open-label, randomized, single-dose, 3-way crossover trial. Thirty-six healthy adults participated in the phase 1 study.
Given the positive results, KalVista will continue to work on the formulation and hopes to have it available as soon as possible after the sebetralstat anticipated launch in the US.
Read about HAE treatment
In addition, KalVista expects to make data from the phase 3 KONFIDENT trial available in the second half of 2023. The clinical stage pharmaceutical company has an oral factor XIIa inhibitor program dedicated to developing a new generation of therapies for HAE.
The US Food and Drug Administration approved several pharmacological agents to manage HAE attacks during the last 2 decades, including Cinryze® (C1-esterase Inhibitor [Human]), Berinert® (C1-esterase Inhibitor [Human]), Kalbitor® (ecallantide), Firazyr® (icatibant), and Ruconest® (C1 Esterase Inhibitor [Recombinant]).
KalVista Pharmaceuticals announces positive phase 1 data for orally disintegrating tablet formulation of sebetralstat for use in hereditary angioedema. News release. KalVista Pharmaceuticals, Inc.; October 31, 2022.