KALV - KalVista's hereditary angioedema drug's orally disintegrating version shows promise in trial

KalVista Pharmaceuticals ( NASDAQ: KALV ) on Monday reported data from a phase 1 trial of an orally disintegrating tablet (ODT) formulation of its drug sebetralstat.

Sebetralstat is currently being developed in a phase 3 trial called KONFIDENT as a therapy for hereditary angioedema (HAE) attacks — a disorder characterized by recurrent episodes (attacks) of severe swelling of the skin and mucous membranes.

The company said data from 36 healthy adult volunteers showed that the ODT tablet formulation has a similar pharmacokinetics (PK) profile to the film-coated version currently in development.

"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," said KalVista CEO Andrew Crockett.

KalVista added that it plans to continue developing this formulation with an aim to make it available after sebetralstat's expected launch in the U.S.

The company expects data from the KONFIDENT study using the film-coated tablets will be available in H2 2023, to support a planned NDA filing in H1 2024.

Earlier in October, KalVista terminated a phase 2 trial, dubbed KOMPLETE, of oral drug KVD824 to prevent HAE attacks after safety concerns related to elevated levels of a liver enzyme were seen.

KALV -1.17% to $5.05 premarket Oct. 31

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