Jerini of Germany has completed patient enrollment in its Phase III trial of its drug icatibant, a bradykinin B2 receptor antagonist, as a treatment for hereditary angioedema.
The study, known as FAST-2, has recruited 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 oedema formation during HAE attacks, is a subcutaneous treatment that is intended to bring about rapid symptom relief.
In a previously-completed Phase II study, icatibant treatment caused relief of symptoms a median time of 27 minutes after administration, in addition to demonstrating good safety, tolerability and pharmacokinetic characteristics.
The FAST-2 trial, along with the US Phase III FAST-1 study, has so far administered 250 open-label treatments to the 130 subjects who have enrolled in the program. Those individuals participating in the assessment are entitled to receive icatibant on an ongoing basis now that the randomization phase has been completed.
Jerini chief executive Jens Schneider-Mergener said that “this milestone marks the completion of randomisation for both the US and European trials.” He added that it is a significant step on the path towards launching the product for use in the treatment of HAE in both territories.
Other companies developing treatments for HAE include Pharming, whose recombinant human C1 inhibitor has just been filed for approval in Europe, as well as Lev Pharmaceuticals’ C1-esterase inhibitor C1-INH (in Phase III) and Dyax Corp’s DX-88 (in Phase II).
