Rigel Pharmaceuticals, Inc. (RIGL) Tuesday said the U.S. Food and Drug Administration has granted Orphan Drug designation to Fostamatinib, Rigel's oral spleen tyrosine kinase or SYK inhibitor which is currently in Phase 3 clinical studies in patients with chronic immune thrombocytopenic purpura or ITP.
Rigel's Phase 3 program for Fostamatinib in ITP, called FIT, has surpassed the half-way point in enrollment and the company expects the program to read out results in mid-2016.
In patients with ITP, the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing.
ITP patients can suffer extraordinary bruising, bleeding and fatigue as a result of low platelet counts. Current therapies for ITP include steroids, blood platelet production boosters and splenectomy.
Rigel believes that Fostamatinib may address the autoimmune basis of the disease.
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