KalVista's genetic disease treatment succeeds in late-stage study

(Reuters) -KalVista Pharmaceuticals said on Tuesday its oral therapy for a type of genetic condition that triggers frequent episodes of swelling met the main goal in a late-stage trial, sending shares up about 30% before the bell.

The life-threatening genetic disease called hereditary angioedema (HAE) causes unpredictable and frequent severe swelling of the skin, gastrointestinal tract, upper respiratory system, face and throat.

Currently approved treatments for HAE in the U.S. include drugs manufactured by Takeda Pharmaceutical and BioCryst Pharmaceuticals.

KalVista's therapy, sebetralstat, was given in 300 milligrams and 600 milligrams doses to patients with HAE and showed beginning of symptom relief significantly faster than placebo during the trial.

The median time to beginning of symptom relief was 1.61 hours with the lower dose version of sebetralstat and 6.72 hours with placebo, said the company.

Last month, Ionis Pharmaceuticals' drug donidalorsen also met the main goal in a late-stage study evaluating it as a treatment for HAE.

Sebetralstat was tested in 136 adult and adolescent patients with HAE — a disease caused by the lack or dysfunction of a certain protein called C1-inhibitor.

KalVista said it was on track to submit a marketing application based on the data to the U.S. Food and Drug Administration in the first half of 2024.

(Reporting by Christy Santhosh; Editing by Shilpi Majumdar)