Rigel Pharma enrolls first patient in Phase 3 autoimmune hemolytic anemia trial
Rigel Pharmaceuticals (NASDAQ:RIGL) enrolled the first patient in its pivotal Phase 3 trial of fostamatinib for the treatment of warm antibody autoimmune hemolytic anemia (AIHA).
AIHA is a rare blood disorder in which the immune system attacks red blood cells. AIHA affects some 40,000 patients in the U.S., and currently has no approved treatment options.
In April 2018, the FDA approved Rigel’s fostamatinib for the treatment of adult patients with chronic immune thrombocytopenia, a disease in which the immune system attacks blood platelets. The drug is commercially available in the U.S. under the brand name TAVALISSE.
“With a clear unmet need, warm AIHA is a very attractive market that is synergistic with our current commercial infrastructure and provides a significant potential opportunity to have a positive impact on patient lives in a second indication,” Raul Rodriguez, Rigels’ president and CEO, said in a statement.
Rigel plans to enroll some 80 patients in the 24-week study, with topline results expected in early 2021.