To date, a total of 121 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. 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. All reported adverse events have been mild and no subjects withdrew from the trial.
The Phase 2 clinical trial of KVD824 will be 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. We expect this trial to initiate in the second quarter of 2021.