Press release
KalVista Pharmaceuticals Reports Third Fiscal Quarter Results
- Enrollment in sebetralstat KONFIDENT phase 3 trial passes 50% milestone; data remains H2 2023– - Sebetralstat phase 2 data published in The Lancet – -
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\n- Enrollment in sebetralstat KONFIDENT phase 3 trial passes 50% milestone; data remains H2 2023–\n\n- Sebetralstat phase 2 data published in The Lancet –\n\n- Company funded into 2025 –\n\n CAMBRIDGE, Mass. & SALISBURY, United Kingdom--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the third fiscal quarter ended January 31, 2023.\n\n“We have made significant advances at KalVista over this quarter, including completing a financing that funds us into 2025, well beyond our phase 3 data results, which remain on track for the second half of this year,” said Andrew Crockett, Chief Executive Officer of KalVista. “We continue to publish sebetralstat data across a wide variety of outlets, including influential medical journals such as The Lancet, and make presentations at prestigious medical and patient meetings. We remain committed to addressing the unmet needs of the hereditary angioedema (HAE) community by providing sebetralstat as a significant advancement in treatment for this disease.”\n\nThird Fiscal Quarter and Recent Business Highlights:\n\n\nReported new data in five posters at the 2023 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The data showed the impact of HAE attacks on anxiety and quality of life in people living with HAE, that sebetralstat significantly decreased cumulative attack and symptom severity while increasing cumulative symptom relief of HAE attacks relative to placebo over a 24-hour period following administration, and that phase 1 data for an orally disintegrating tablet formulation supported further clinical development of that formulation.\n\n\nProvided multiple progress updates on sebetralstat development, including the announcement that KalVista has enrolled more than 50% of the targeted number of patients in the pivotal phase 3 KONFIDENT clinical trial. In addition, the Company received FDA regulatory guidance that efficacy trials are not required to support a supplemental NDA (sNDA) filing for the orally disintegrating tablet (ODT) formulation of sebetralstat. KalVista also received guidance from the Japanese regulatory authority (PMDA) on th...