At the 12th C1-Inhibitor Deficiency & Angioedema Workshop, KalVista Pharmaceuticals, Inc. presents clinical data supporting KVD900 as an oral on-demand treatment for HAE.
“Our goal is to provide the best outcome for HAE patients experiencing an attack, and that means offering them the ability to treat early in the attack progression to shorten attack duration,” says Andrew Crockett, CEO of KalVista. “The data reinforce that attacks treated with oral KVD900 experience a rapid improvement in symptoms which is maintained for 24 hours, while also being generally safe and well tolerated. We look forward to providing updates on KVD900’s upcoming Phase 3 program.”
Following is a brief summary of the presentation “Fast improvement of hereditary angioedema (HAE) attacks with the oral on-demand plasma kallikrein inhibitor KVD900: an analysis of the pharmacokinetic and pharmacodynamic profile of KVD900 and attack symptom severity during a double-blind, randomized phase 2 cross-over trial in patients with HAE type I and II” given by Andrea Zanichelli, MD:
- KVD900 achieves rapid plasma exposures, with near complete plasma kallikrein inhibition within 30 minutes.
- Attacks treated with KVD900 experienced a rapid improvement in the most severe baseline symptoms both in absolute terms and relative, when expressed as change from baseline. This improvement was maintained for 24 hours.
- KVD900 significantly accelerated improvement in attack severity as assessed using a composite Visual Analog Scale (VAS). A 50% reduction in the composite VAS was reached for 50% of the attacks treated with KVD900 within six hours versus greater than 12 hours for attacks treated with placebo. By 24 hours, 74% of KVD900-treated attacks showed a 50% reduction in score compared to 38% for placebo-treated attacks.
- Adverse events were of mild or moderate intensity with no severe or serious adverse events reported. Overall, the single administration of KVD900 appeared safe and well tolerated.