{"id":53824,"date":"2023-02-10T13:02:26","date_gmt":"2023-02-10T12:02:26","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/kalvista-pharmaceuticals-announces-publication-of-sebetralstat-phase-2-data-in-the-lancet\/"},"modified":"2023-02-10T13:02:26","modified_gmt":"2023-02-10T12:02:26","slug":"kalvista-pharmaceuticals-announces-publication-of-sebetralstat-phase-2-data-in-the-lancet","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/kalvista-pharmaceuticals-announces-publication-of-sebetralstat-phase-2-data-in-the-lancet\/","title":{"rendered":"KalVista Pharmaceuticals Announces Publication of Sebetralstat Phase 2 Data in The Lancet"},"content":{"rendered":"
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CAMBRIDGE, Mass. & SALISBURY, England–(BUSINESS WIRE)–$KALV<\/a>—KalVista Pharmaceuticals, Inc.<\/a> (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.<\/i>\n<\/p>\n

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\nThe 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.\n<\/p>\n

\n\u201cAll 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,\u201d said Dr. Emel Ayg\u00f6ren-P\u00fcrs\u00fcn, 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. \u201cIn 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.\u201d\n<\/p>\n

\n\u201cSebetralstat was rapidly absorbed after oral administration, halting attack progression and expediting symptom relief and attack resolution,\u201d added Dr. Andrea Zanichelli, Unit\u00e0 di Medicina, IRCCS Policlinico San Donato, Universit\u00e0 degli Studi di Milano, and co-lead author. \u201cImportantly, 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.\u201d\n<\/p>\n

\n\u201cThe publication of these phase 2 results in The Lancet<\/i> 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,\u201d said Andrew Crockett, Chief Executive Officer of KalVista. \u201cWe 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.\u201d\n<\/p>\n

\nThe publication abstract can be found at the below link:\n<\/p>\n

\nAn investigational oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema: a two-part, randomised, double-blind, placebo-controlled, crossover phase 2 trial – The Lancet<\/a>\n<\/p>\n

\nTopline Phase 2 Sebetralstat Results<\/b>\n<\/p>\n