Rigel shares fall 60% after Syk inhibitor fostamatinib phase III study fails

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Rigel shares fall 60% after Syk inhibitor fostamatinib phase III study fails

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Rigel shares fall 60% after Syk inhibitor fostamatinib phase III study fails.

On June 8, Rigel Pharmaceuticals announced that the Syk inhibitor fostamatinib (fotatinib) for the treatment of warm antibody autoimmune hemolytic anemia (wAIHA) global, multicenter, randomized, double-blind, placebo-controlled Phase III The FORWARD trial did not meet its primary endpoint.

Affected by the news, Rigel shares fell 60%.

Autoimmune hemolytic anemia (AIHA) is a rare and debilitating serious blood disorder.

The body’s own red blood cells are destroyed when antibodies produced by the immune system react with red blood cells.

Warm antibody AIHA (wAIHA) is the most common form of AIHA and is characterized by the presence of antibodies that react with the surface of red blood cells at normal body temperature.

In the United States, approximately 36,000 adult patients are affected by wAIHA. To date, there are no targeted therapy drugs approved for wAIHA.

Fostamatinib, approved in the U.S. under the trade name Tavalisse, is the first and only FDA-approved Syk inhibitor for the treatment of adult patients with chronic primary immune thrombocytopenia (ITP) who have had an inadequate response to prior therapy.

The 90 subjects participating in the trial were drawn from three pre-designated geographic regions, including 14 sites in the United States, Canada, and Australia; and 16 sites each in Western and Eastern Europe.

Patients were randomized 1:1 to receive fostamatinib or placebo twice daily for 24 weeks. The primary efficacy endpoint was persistent hemoglobin (Hgb) response.

Defined as the proportion of subjects who achieved Hgb ≥10 g/dL and increased ≥2 g/dL from baseline during three consecutive visits during the 24-week treatment period.

Across the entire study population, there was no statistically significant difference in the primary endpoint of persistent hemoglobin response with fostamatinib compared with placebo.

However, in post hoc regional analyses at trial sites in the United States, Canada, Australia, and Western Europe, patients treated with fostamatinib had favorable durable hemoglobin responses compared with placebo, but not in the Eastern European trial sites.

Rigel plans to continue analyzing the data to understand geographic differences in patient disease characteristics and outcomes, and to discuss these findings with the FDA.

Fostamatinib was generally well tolerated. The safety profile in this trial was consistent with previous clinical experience, and no new safety concerns were identified.

Rigel shares fall 60% after Syk inhibitor fostamatinib phase III study fails

(source:internet, reference only)

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