KVD824 for HAE

KVD824 is our twice-daily oral plasma kallikrein inhibitor for prevention of HAE attacks. We submitted an Investigational New Drug (IND) submission for a Phase 2 clinical trial of KVD824 in the first quarter of 2021. KVD824 was initially evaluated in a three-part first-in-human study in which 84 subjects received at least one dose of KVD824. The study evaluated single doses up to 1280 mg, multiple doses up to 640 mg, and the effect of food on KVD824 pharmacokinetics.

We have also completed a study in healthy adult subjects assessing different formulations of KVD824. Formulations of both 600 mg and 900 mg KVD824 administered twice-daily maintained concentrations we believe will deliver meaningful clinical efficacy.

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.

Scientist

Phase 2

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.