Positive results for icatibant in HAE trials

German drugmaker Jerini AG says that the results of two pivotal Phase III trials (FAST-1 and -2) of its drug icatibant, a bradykinin B2 receptor antagonist, show that it may have efficacy in relieving the symptoms of hereditary angiodema (HAE).

The FAST-1 study, which compared the drug with placebo in the treatment of HAE, produced clinically-relevant data but did not meet its primary endpoint of a 2.5 hour average time to symptom relief. The firm said that this was due to the unexpected level of response to placebo.

In the FAST-2 trial the drug's efficacy was compared with that of tranexamic acid, in 74 HAE patients at centers in Europe and Israel. Analysis of the data revealed that the drug had achieved its primary endpoint, yielding a median time to symptom relief of two hours, compared with the tranexamic acid cohort which experienced symptom relief 12 hours post-administration.