KalVista Pharmaceuticals announced the dosing of the first subject in a first-in-human clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of orally delivered KVD818 in healthy volunteers. A KalVista discovery, KVD818 is a novel, potent, and selective inhibitor of plasma kallikrein in development for the prevention of attacks of edema in patients with hereditary angioedema (HAE).
Andrew Crockett, KalVista’s CEO, said, “The successful dosing of the first subject in this first-in-human clinical trial is an important milestone for the KVD818 development program and a first step in our goal of developing a best in class oral plasma kallikrein inhibitor for HAE. We believe that an oral drug for the treatment of HAE will be an important advancement for patients who suffer from this condition.”
This first clinical study will provide data to evaluate the key characteristics of safety, drug exposure and bioactivity (plasma kallikrein inhibition) achieved after oral dosing of KVD818. This clinical trial is being conducted in the United Kingdom and the results of this study are expected to be announced in the first half of 2017. If the phase 1 program achieves its goals, KalVista plans to initiate a phase 2 trial in HAE patients.
Hereditary angioedema (HAE) is a rare and potentially life-threatening genetic condition that occurs in fewer than 1 in 10,000 people. HAE patients are susceptible to sudden and prolonged attacks of edema, which often occur in the hands, feet, face, gastrointestinal tract, and airway. Attacks can result in severe swelling and pain, airway blockage, and nausea. Treatment of HAE consists of both prophylaxis and management of acute attacks.