KalVista Pharmaceuticals, Inc. announced that results from the phase 2 trial evaluating the efficacy and safety of oral sebetralstat for the on-demand treatment of hereditary angioedema (HAE) attacks has been published in the international weekly medical journal, The Lancet. The phase 2 study was a two-part, randomized, double-blind, placebo-controlled clinical trial. The trial included a total of 68 patients with HAE and showed that oral sebetralstat was well tolerated and led to rapid suppression of plasma kallikrein activity, resulting in significantly increased time to use of conventional treatment, reduced attack severity, and faster time to symptom relief and resolution compared to placebo.

Topline Phase 2 Sebetralstat Results: Time to use of conventional treatment within 12 h of study drug administration was significantly longer with sebetralstat versus placebo; (p=0·0010); Sebetralstat significantly reduced time to onset of symptom relief (p=<0.0001) on the Patient Global Impression of Change scale (PGI-C), with a median time of 1.6 hours versus 9 hours for attacks treated with placebo; Time to conventional attack treatment use or worsening in severity by 1 level or more on the PGI-S, whichever came first, within 12 h of study administration was significantly longer after treatment with sebetralstat than after treatment with placebo (p<0.001); The median time to attack resolution, defined as a PGI-S rating of “none” within 24 h after study drug administration, was significantly shorter with sebetralstat than with placebo (p=0·0021); Sebetralstat was well-tolerated and no serious adverse events were reported. The proportion of drug-related treatment-emergent adverse events was similar in attacks treated with sebetralstat and placebo.