How does KVD824 work?
Many patients with HAE have low levels of C1 esterase inhibitor, an enzyme that controls the levels of another enzyme, plasma kallikrein. Plasma kallikrein increases the levels of a molecule called bradykinin, leading to higher permeability (how easily things flow through a barrier) of blood vessels and leakage of fluid into the surrounding tissue. The extra fluid leads to the swelling that HAE patients experience.
KVD824 is an oral medication that acts as an inhibitor of plasma kallikrein, keeping the enzyme from increasing levels of bradykinin in the body so as to prevent HAE attacks.
KVD824 in clinical trials
Researchers tested KVD824 in a Phase 1 clinical trial in 84 healthy volunteers. Participants received either a single dose of up to 1,280 mg or multiple doses of up to 640 mg each of KVD824. The trial investigated the safety, tolerability, and pharmacokinetics (movement in the body) of the treatment at each of the doses. Researchers also studied the effect of food on pharmacokinetics. Participants tolerated all doses well with no serious side effects and no one withdrawing from the study.
Another study is currently underway in the U.K. assessing single and multiple doses of KVD824 in healthy volunteers. Sixteen participants received one of six different single doses of treatment ranging from 600 mg to 900 mg. Another group of participants received twice-daily doses for 14 days. Results of the trial so far have shown that 600 mg taken twice a day achieved concentrations high enough to be effective and that patients taking 900 mg twice a day were able to still tolerate the treatment but achieve even higher concentrations.
Based on the results of these two preliminary studies, KalVista plans to file an investigational new drug application with the U.S. Food and Drug Administration in early 2021. If given the go-ahead by regulators, the company will start recruiting patients with HAE for a Phase 2 clinical trial to investigate the safety and efficacy of KVD824 as a twice-daily treatment to prevent HAE attacks. KalVista expects to conduct the trial in multiple territories including the United States and Europe.
Last updated: Dec. 16, 2020
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