CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors today 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.
“All currently available on-demand treatments in HAE require injections and are associated with substantial treatment burden and delays due to the time required for medication preparation and administration, and associated pain and discomfort,” said Dr. Emel Aygören-Pürsün, Head of the HAE Center at the University Hospital Frankfurt, co-lead author of the manuscript, and Principal Investigator for the phase 2 clinical trial. “In this study, patients were able to orally administer treatment early after attack onset, minimizing time to improvement. This suggests that sebetralstat has the potential to enable patients to improve clinical outcomes.”
“Sebetralstat was rapidly absorbed after oral administration, halting attack progression and expediting symptom relief and attack resolution,” added Dr. Andrea Zanichelli, Unità di Medicina, IRCCS Policlinico San Donato, Università degli Studi di Milano, and co-lead author. “Importantly, sebetralstat was well-tolerated in this trial with very few adverse events. The preliminary safety profile contrasts favorably with the labelled adverse reactions for currently approved on-demand therapies.”
“The publication of these phase 2 results in The Lancet underscores their significance and represents further validation of the promise of sebetralstat as potentially the first oral on-demand treatment for people living with HAE,” said Andrew Crockett, Chief Executive Officer of KalVista. “We anticipate clinical results from our ongoing phase 3 KONFIDENT trial for sebetralstat for on-demand treatment in HAE in the second half of this year as we work to bring this innovative therapy to the HAE community.”
The publication abstract can be found at the below link:
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=