KalVista Says Sebetralstat's Orally Disintegrating Formulation At Par With Film-Coated Version For HAE Attacks

KalVista Pharmaceuticals Inc KALV announced 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 trial as a potential on-demand treatment for hereditary angioedema (HAE) attacks.
The phase 1 trial enrolled 36 healthy adult volunteers to compare the pharmacokinetics (PK) of sebetralstat following the administration of ODT and the current film-coated tablets in healthy adult volunteers.
Also Read: KalVista Shares Plunge After Ending KVD824 HAE Trial Over Elevated Liver Enzymes In Patients.
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 developing the formulation to make it available as soon as possible after the sebetralstat anticipated launch in the U.S.
KalVista expects data from the KONFIDENT study using the film-coated tablets will be available in the second half of 2023, to support a planned marketing application filing in the first half of 2024.
Price Action: KALV shares are down 1.08% at $5.06 on the last check Monday.