Press release
KalVista Pharmaceuticals Announces Initiation of KVD900 Phase 3 KONFIDENT Clinical Trial
-KONFIDENT to Evaluate KVD900 As First Oral On-Demand Therapy for HAE- -KONFIDENT Designed to Support Broad Label for Treatment of All HAE Attacks-
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\n-KONFIDENT to Evaluate KVD900 As First Oral On-Demand Therapy for HAE-\n\n-KONFIDENT Designed to Support Broad Label for Treatment of All HAE Attacks-\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 oral, small molecule protease inhibitors, today announced the initiation of the Phase 3 KONFIDENT clinical trial evaluating the efficacy and safety of KVD900 as the first potential oral, on-demand therapy for hereditary angioedema (HAE) attacks. This worldwide, double-blind, placebo-controlled crossover trial will evaluate the efficacy of two dose levels of KVD900 compared to placebo in adolescents and adults experiencing acute HAE attacks. KVD900 is the most advanced potential oral on-demand therapy for HAE in clinical development, and is intended to provide a substantial improvement over the current on-demand therapies for HAE attacks, which are all delivered by injection.\n\n“Beginning the KONFIDENT trial represents a major milestone for KalVista,” said Andrew Crockett, Chief Executive Officer of KalVista. “We believe that KVD900 has the potential to transform the treatment paradigm for HAE patients experiencing acute attacks, whether they primarily treat with on-demand medications or use long-term prophylaxis. Based upon the results of our Phase 2 study released last year, we expect that KVD900 can provide patients with symptom relief as rapidly as existing therapies, but with an oral tablet that will allow earlier treatment of all patient-recognized HAE attacks. Our goal is to provide patients with the confidence that their attacks will be controlled in the earliest stages and without the associated treatment pain and other challenges of injectable therapies.”\n\nThe Phase 3 KONFIDENT trial is a worldwide clinical study being conducted at approximately 60 sites in 20 countries. The trial is intended to enroll a minimum of 84 HAE adolescent and adult patients who will complete treatment of three attacks: one each with 300 mg KVD900, 600 mg KVD900 and placebo in a double-blinded, randomized sequence. The primary endpoint of the trial is time to the beginning of symptom relief, evaluated on a Patient Global Impression of Change (PGI-C) scale, and additional endpoints ...