In the study, the drug showed a clinically and statistically significant reduction in the number of hereditary angioedema (HAE) attacks.
Based on the positive results of this study, the company intends to amend its biologics license application for Cinryze (C1 inhibitor), which was submitted to the FDA to include the prevention of HAE attacks. Cinryze is being developed as a replacement therapy for both the acute and prophylactic treatment of HAE.
In the 24-week, double-blind, placebo controlled study, a total of 24 patients were randomly assigned to one of two treatment groups: twelve weeks of Cinryze treatment followed by 12 weeks of placebo or 12 weeks of placebo treatment followed by 12 weeks of Cinryze. Patients received twice-weekly doses of Cinryze or placebo.
The primary endpoint was met with a 53% reduction in the number of attacks in the Cinryze group. Secondary endpoints in the study also showed highly significant differences in favor of Cinryze, including a 66% reduction in days of swelling and decreases in the average severity of attacks and average duration of attacks.
“The results of this study, combined with the results of our acute trial, support the potential of Cinryze to become a comprehensive treatment option for HAE patients in the US,” said Joshua Schein, Lev's CEO.