Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE

A Phase 2a Double-Blind Placebo-Controlled 2-Period Crossover Study to Evaluate the Safety and Efficacy of BCX4161 as a Prophylactic Treatment to Reduce the Frequency of Attacks in Subjects With Hereditary Angioedema

The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic treatment is safe and effective in reducing the number of acute attacks in patients with hereditary angioedema.

Key Inclusion Criteria:

• Written informed consent
• Clinical and laboratory diagnosis of Hereditary Angioedema Type I or II
• An average angioedema attack frequency of 1/week
• Acceptable birth control measures

Key Exclusion Criteria:

• Concurrent use of defined treatments for prophylaxis
• Pregnancy or breast-feeding
• Clinically significant medical condition, laboratory abnormality or medical history