KalVista Pharmaceuticals said Tuesday that its oral, on-demand treatment for the swelling “attacks” commonly experienced by patients with a genetic condition called hereditary angioedema achieved the goals of a Phase 3 clinical trial.
Based on the study results, the company plans to submit a marketing application to the Food and Drug Administration by the middle of the year. Regulatory filings in Europe and Japan will be completed later in the year.
In the Phase 3 study involving 136 participants, a low and high dose of Kalvista’s drug, called sebetralstat, showed a median time to the beginning of symptom relief of 1.6 hours and 1.8 hours, respectively, compared to 6.7 hours for a placebo. The result was statistically significant and achieved the study’s main efficacy goal.