KalVista Pharmaceuticals Provides Development Update and 2019 Clinical Plans
– KVD900 Phase 2 HAE Trial Data Expected in 2019 –
– KVD824 Named as Next Oral Plasma Kallikrein Inhibitor to
“In December we filed with regulatory authorities to begin our Phase 2
study of KVD900 as a potential oral acute treatment for hereditary
angioedema, or HAE. As previously announced, 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,”
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.
For more information, please visit www.kalvista.com.
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, available funding, our cash runway and future clinical trial timing and results. Further information on potential risk factors that could affect our business and its financial results are detailed in the annual report on Form 10-K filed on
KalVista Pharmaceuticals, Inc.
Director, Corporate Communications & Investor Relations