98 subjects have been exposed to treatment with KVD824 as single doses up to 1280 mg and up to 14 days of twice-daily dosing of 600 mg and 900 mg and there have been no concerning safety or tolerability signals. In the first-in-human study adverse event rates were similar in placebo and active arms. No subjects withdrew from the study and no serious adverse events were reported. In the ongoing formulation study, all reported adverse events to date have been mild and no subjects have withdrawn from the study. We will release the full safety data set upon completion of the study.
The Phase 2 clinical trial of KVD824 is intended to evaluate the efficacy and safety of KVD824 as a twice-daily prophylactic treatment for prevention of HAE attacks. The study size will be guided by previous pivotal studies, considering the already established pathway to approval for prophylactic treatment of HAE, and will be conducted in multiple territories including the United States and Europe.