The treatment candidate is administered as an injection under the skin.
How SHP616 works
SHP616 contains an enzyme called C1 esterase inhibitor that controls the amount of a substance called bradykinin. Patients with hereditary angioedema have low levels of this enzyme, which means that they are at risk of accumulating higher-than-normal amounts of bradykinin.
Excessive bradykinin levels increase the permeability of blood vessels, leading to the classic symptoms of an HAE attack — swelling of the airways, intestinal tract, limbs, and face.
By restoring normal levels of the C1 esterase inhibitor, SHP616 can prevent HAE attacks.
SHP616 in clinical trials
Shire evaluated SHP616’s ability to prevent attacks in a Phase 3 clinical trial (NCT02584959) that ended in July 2017. In the first 14 weeks of the study, 75 patients with type 1 or 2 HAE who had experienced at least two attacks a month for three months received SHP616 every three to four days or a placebo. The patients then switched treatment groups for the next 14 weeks. A third group received SHP616 the entire seven months of the trial without a placebo.
Participants experienced a 79 percent reduction in attack rates, researchers said. Three-quarters were able to cut their attacks in half. Thirty-eight percent of patients had no attacks at all while taking SHP616.
Patients had no severe side effects during the trial. The most common adverse events were infections of the upper airways and headaches. In addition, no patients experienced a clotting event. The trial occurred in the U.S, Canada, Germany, Hungary, Romania, and Spain.
Other types of C1 esterase inhibitor therapies are Cinryze, also developed by Shire, and Haegarda and Berinert, both sold by CSL Behring. Haegarda is given as injections under the skin, while Berinert and Cinryze are given as injections directly into the bloodstream.
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