LL schreef op 9 maart 2022 07:00:
KalVista Pharmaceuticals Announces Initiation of KVD900 Phase 3 KONFIDENT Clinical TrialMarch 7, 2022 at 6:30 AM EST
-KONFIDENT to Evaluate KVD900 As First Oral On-Demand Therapy for HAE-
-KONFIDENT Designed to Support Broad Label for Treatment of All HAE Attacks-
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Mar. 7, 2022-- 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 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.
The 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 will evaluate other measures of patient response and attack progression, as well as safety. Patients will dose upon first recognition of an attack, and all attack types including laryngeal attacks will be eligible for treatment. Patients will be permitted to take an additional dose of investigational drug, if symptoms warrant, and will always have access to their conventional injectable therapy. Study participants also will be allowed to maintain their prophylaxis regimen if they were receiving one at study enrollment.