“In December we filed with regulatory authorities to begin our Phase 2 study of KVD900 as a potential oral acute treatment for HAE. This enlarged study is expected to provide data in late 2019. We continue to be excited by the potential for KVD900 to provide a safe, oral on-demand option for HAE patients to more conveniently and effectively manage their disease,” says Andrew Crockett, CEO of KalVista Pharmaceuticals, Inc. “We are also pleased to announce that we made the regulatory filings for our next oral plasma kallikrein inhibitor, KVD824, and expect to begin dosing that first-in-human trial soon. We expect to provide a further update on KVD824 around mid-year.”
Following the necessary regulatory approvals, the Phase 2 trial evaluating KVD900 as an on-demand treatment for HAE attacks will begin dosing in approximately 50 patients at over 10 European clinical sites. The study will recruit type 1 and 2 HAE patients who have had three attacks in 90 days prior to enrollment. During the first part of this two-part study patients will receive a single 600 mg dose of KVD900 to explore pharmacokinetic and pharmacodynamic properties. All patients will then enter part two of the study, which is a crossover investigation in which the efficacy of KVD900 will be assessed versus placebo across two attacks. Patients experiencing an attack will take a single dose of 600 mg of KVD900 or placebo within one hour of the start of the attack. The second attack will be dosed with the other treatment. For all attacks, symptom severity will be monitored and additional data points will be collected for at least 24 hours. Patients will use their normal, on-demand treatment as required.