Benzinga | Dec 4, 2020 07:33AM EST

Rigel Pharma Highlights 2 Poster Presentations Will Be Presented At American Society Of Hematology Dec. 5-8

Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that data related to TAVALISSE(r) (fostamatinib disodium hexahydrate) tablets will be presented in two poster presentations at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition to be held virtually December 5-8, 2020. The poster presentations will be made available on the event's website at https://www.hematology.org/meetings/annual-meeting on Saturday, December 5 at 7:30am PT.

Rigel will present an analysis of long-term safety data on fostamatinib in more than 3,500 patients at various dosing regimens with immune thrombocytopenia (ITP) or rheumatoid arthritis (RA). No new safety signals nor cumulative toxicity were observed with up to 62 months (5.2 years) of continuous treatment in ITP patients and up to 81 months (6.8 years) of continuous treatment in RA patients.

An overview of Rigel's ongoing Phase 3 clinical trial of fostamatinib in warm autoimmune hemolytic anemia (wAIHA) will also be presented. This is a randomized, double-blind, placebo-controlled study of approximately 90 patients with primary or secondary wAIHA who have failed at least one prior treatment. This study is based on Rigel's Phase 2, open-label, multi-center study for the treatment of wAIHA. Results of that study demonstrated that 44% (11/25) of patients had markedly improved hemoglobin (Hgb) levels and adverse events were consistent with those in the fostamatinib safety database.

Additionally, Rigel's planned Phase 3 clinical trial to evaluate the efficacy and safety of fostamatinib in adult, hospitalized COVID-19 patients was featured in an ASH abstract published in the November 26, 2020, issue of Blood. This is a multi-center, double-blind, placebo-controlled, adaptive design study with a primary endpoint that measures the proportion of subjects who progress to severe/critical disease within 29 days.

Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE(r) (fostamatinib disodium hexahydrate) tablets, which is the first and only spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. The FDA has granted TAVALISSE Orphan Drug designation for the treatment of patients with warm AIHA.

Poster Presentations

Abstract #838

Long-Term Safety Profile of the Oral Spleen Tyrosine Kinase Inhibitor Fostamatinib in Immune Thrombocytopenia (ITP) and Other Diseases

Presenter: Aaron Sheppard, PhD

Session Name: 311. Disorders of Platelet Number or Function: Poster I

Date & Time: Saturday, December 5, 2020: 7:00 AM-3:30 PM PT

Abstract #752

Fostamatinib for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (wAIHA): A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study

Presenting Author: Nichola Cooper, MD

Session Name: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster I

Date & Time: Saturday, December 5, 2020: 7:00 AM-3:30 PM PT