Dyax (DYAX $1.98 -0.16) announced the decision to discontinue its Phase 2 trial investigating ecallantide in the acute treatment of angiotensin converting enzyme (ACE) inhibitor-induced angioedema based upon the results of an interim analysis. This double-blind, placebo-controlled, randomized, dose-ranging study was designed to evaluate the efficacy and safety of ecallantide (10, 30, or 60 mg subcutaneous doses) compared to placebo, with a goal of enrolling 176 patients.
The primary endpoint was the proportion of patients meeting a set of criteria indicating eligibility for discharge from the emergency department within 6 hours following study drug administration. Safety was not a factor in the Company's decision to stop the clinical trial. Separately from this interim analysis of the efficacy data, an independent Data Safety Monitoring Board (DSMB) met on May 15, 2012, and reviewed blinded safety data for the first 25% of patients enrolled in the trial. The DSMB did not identify any safety concerns and did not recommend any changes to the conduct of the study.