Shire’s subcutaneous HAE candidate meets in Phase III

Shire plc (LSE:SHP; NASDAQ:SHPG) said SHP616 met the primary endpoint in the Phase III SAHARA trial to treat symptomatic hereditary angioedema in patients ages 12 and older. SHP616 is a lower-dose volume, subcutaneous liquid formulation of IV Cinryze, the company's marketed complement 1 (C1) esterase inhibitor.

In the 75-patient trial, 2,000 IU SHP616 given every three to four days as a single 4 mL subcutaneous injection significantly reduced the mean HAE attack rate by 2.32 attacks/month vs. placebo (p<0.0001)...