Business
KalVista Pharmaceuticals Provides Update on Oral Hereditary Angioedema Franchise
– KVD900 Phase 2 Trial Recruitment Complete; Data Expected Before End of 2020 – – KVD824 Achieves Targeted Exposure Levels for Prophylaxis; IND Submission
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\n– KVD900 Phase 2 Trial Recruitment Complete; Data Expected Before End of 2020 –\n\n– KVD824 Achieves Targeted Exposure Levels for Prophylaxis; IND Submission Expected Q1 2021 –\n\n– Oral Factor XIIa Inhibitor Program Announced –\n\n CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today provided an update on its franchise of oral therapies for treatment of hereditary angioedema (HAE).\n\n“We have completed enrollment of our Phase 2 trial for our oral on-demand HAE treatment, KVD900, and remain on track to deliver data before the end of this year. We are also pleased to announce data from KVD824, our oral program for HAE prophylaxis, and to introduce our oral Factor XIIa program, which we believe represents the next generation of HAE therapeutics,” said Andrew Crockett, Chief Executive Officer of KalVista. “Our ongoing work to optimize the exposure profile of KVD824 has yielded a formulation that maintains the concentrations we believe are required to compete with approved injectable therapies, while showing an encouraging safety and tolerability profile in up to 14 days of dosing. We intend to submit an Investigational New Drug application for a Phase 2 study to evaluate KVD824 in prevention of HAE attacks in the first quarter of 2021. Looking to the future, we are also excited to share early data on our oral Factor XIIa inhibitor program as an additional HAE therapy, with IND-enabling studies anticipated in 2021.”\n\nAbout KVD824\nKVD824 is our twice-daily oral plasma kallikrein inhibitor for prevention of HAE attacks. We initially evaluated KVD824 in a three-part first-in-human study in which 84 subjects received at least one dose of KVD824. The study evaluated single doses up to 1280 mg, multiple doses up to 640 mg, and the effect of food on KVD824 pharmacokinetics.\n\nWe are currently conducting a study in the UK assessing both single and multiple dose formulations of KVD824. Six formulations of 600 to 900 mg have been assessed in 16 healthy subjects in a cross-over single dose phase. Selected formulations are being evaluated for 14 days, dosing two times daily, up to 900 mg per dose in a multiple dose phase. 600 mg of KVD824 twice...