Jerini sees progress in Icatibant HAE study

German drugmaker Jerini AG says that it has completed the randomization of the last patient to enroll in a Phase III trial of its drug Icatibant, a bradykinin B2 receptor antagonist, as a potential treatment for hereditary angiodema. The study, known as FAST-2 (For Angioedema Subcutaneous Treatment), has enrolled a total of 74 subjects at 31 research centers across Europe and is designed to examine the drug in comparison with tranexamic acid.

HAE is caused by a malfunction in the C1 esterase inhibitor enzyme that results in the build up of an excess of the vasodilation- and permeability-inducing bradykinin peptide in the blood stream.

The drug, which is a synthetic peptidomimetic designed to reduce edema formation during HAE attacks, is a subcutaneous treatment that is intended to bring about rapid symptom relief. In a previously-completed Phase II study, treatment with the product resulted in patient-assessed relief at a median time of 27 minutes after administration, in addition to demonstrating good safety, tolerability and pharmacokinetic characteristics.