Jerini of Germany said yesterday reported the results of its two pivotal Phase III trials of its bradykinin B2 receptor antagonist icatibant in the treatment of hereditary angioedema (HAE), saying that it intends to press ahead with filing for approval of the drug in Europe and the USA before the end of the year.
One of the studies – dubbed FAST-1 – failed to reach its primary endpoint of a significant reduction in the time to onset of symptom relief with icatibant, but Jerini said the results were ‘clinically relevant’ and supported the findings of the second study, FAST-2.
The latter study did meet its primary objective of reducing the time to symptom relief, while secondary endpoints, such as patient and physician reported time to first improvement of symptoms, and the time to almost complete relief of symptoms showed highly significant results in favour of icatibant in both studies.
Jens Schneider-Mergener Jerini’s chief executive, said: "We are looking forward to presenting these data to the US Food and Drug Administration and European medicines Agency, and will continue with our plans to begin submission for regulatory approval in December 2006.
“HAE patients are in need of a reliable treatment allowing them to manage their disease themselves,” he added.
HAE is a debilitating and potentially life-threatening genetic disease characterised by unpredictable recurring swelling attacks in the hands, feet, face, larynx, and abdomen. It 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.
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).