Shire's subcutaneous HAE candidate meets in Phase III

Shire plc (LSE:SHP; NASDAQ:SHPG) reported top-line data from the Phase III SAHARA trial in 75 patients ages 12 and older with symptomatic hereditary angioedema (HAE) showing that 2,000 IU SHP616 given every 3-4 days as a single 4 mL subcutaneous injection met the primary endpoint of reducing the mean HAE attack rate vs. placebo. Specifically, SHP616 reduced the mean HAE attack rate by 2.32 attacks/month vs. placebo (p<0.0001).

On secondary endpoints, 78% of patients who received SHP616 achieved a ≥50% reduction in the rate of HAE attacks compared to placebo. Compared to placebo, SHP616 reduced the median HAE attack rate by 79% from baseline and by 85% from day 14 after reaching steady state. Additionally, 38% of patients were attack free during their SHP616 treatment period vs. 9% of patients during their placebo treatment period. No treatment-related serious adverse events or deaths were reported...