25 August 2022 - - US-based pharmaceutical company KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) has initiated the KONFIDENT-S open label extension study for its ongoing Phase 3 KONFIDENT study of sebetralstat for the on-demand treatment of hereditary angioedema attacks, the company said.

The KONFIDENT-S trial is evaluating sebetralstat, an oral plasma kallikrein inhibitor designed for the on-demand treatment of HAE attacks in adults living with HAE, and a subtrial will allow participation by adolescents 12-17 years of age.

The trial will also evaluate sebetralstat for use as a short-term prophylaxis treatment prior to medical procedures.

Data from the KONFIDENT-S trial will be available in the second half of 2023 to support the company's planned NDA filing for sebetralstat in 2024. Initiation of this OLE study follows submission to the FDA of pivotal toxicology studies intended to support the eventual NDA filing.

KalVista Pharmaceuticals is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need.

The company has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema and diabetic macular edema.

KalVista is developing sebetralstat as an oral on-demand therapy for HAE attacks and is enrolling the Phase 3 KONFIDENT clinical trial.

KVD824 is in development for prophylactic treatment of HAE, with the Phase 2 KOMPLETE clinical trial underway.

In addition, KalVista's oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment for people living with HAE.

In DME, an intravitreally administered plasma kallikrein inhibitor, called KVD001, has completed a Phase 2 clinical trial.