KVD824 for HAE

KVD824 is our twice-daily oral plasma kallikrein inhibitor for the prevention of HAE attacks. 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.

KOMPLETE is the Phase 2 clinical trial of KVD824, and is a randomized, double-blind, parallel group design evaluating twice-daily dosing of 300 mg, 600 mg, and 900 mg KVD824 against placebo for 12 weeks. The trial will enroll 48 HAE patients randomized into four equal arms after they report experiencing a minimum of three attacks in an eight-week run-in period. The primary endpoint of the trial is the rate of investigator confirmed HAE attacks during the treatment period. Secondary endpoints include the proportion of participants without investigator confirmed HAE attacks and the rate of investigator confirmed HAE attacks that require conventional treatment. KOMPLETE will be conducted at more than 30 sites in 13 countries.

KOMPLETE

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. The formulation of KVD824 maintains the plasma concentrations that we believe are required to deliver efficacy consistent with approved injectable therapies. Twice-daily dosing of KVD824 up to 14 days has demonstrated an encouraging safety and tolerability profile.