The randomized double-blind placebo-controlled study with Rhucin was conducted at several sites in the US and Canada. On having an acute hereditary angioedema (HAE) attack, 39 patients were randomized to one of two doses of Rhucin (100U/kg, 50U/kg) or placebo.
For the primary endpoint, the intent-to-treat analysis demonstrates that patients who received the 100U/kg dose of Rhucin reported median first symptom relief at approximately 68 minutes, those that received the 50U/kg dose reported relief at approximately 100 minutes, and those that received placebo reported symptom relief at approximately 258 minutes.
The time to minimal clinical symptoms, the secondary endpoint, was reported by patients in the 100U/kg, 50U/kg, placebo groups as approximately 245, 247, and 1098 minutes, respectively.
The primary and secondary endpoint results with both doses of Rhucin were clinically meaningful and statistically significant relative to placebo with p-values < 0.01. There was no statistically significant difference observed between patients treated with 100U/kg or 50U/kg dose of Rhucin. Based on these results, Pharming intends to file regulatory submissions for Rhucin in several early launch markets in the second half of 2008 and will meet with European Medicenes Agency and FDA to accelerate regulatory filings in Europe and the US.