Rigel's Oral Spleen Tyrosine Kinase Inhibitor Meets Primary Endpoint In Final Stage Trial In Chronic ITP
Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) disclosed that fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, met the primary endpoint in the final stage trial program for adult chronic/persistent immune thrombocytopenia treatment. This is one of the first of two double-blind trials in the FIT Phase 3 clinical program.
Rigel said the trial demonstrated 18 percent of patients receiving fostamatinib achieved a stable platelet response. In comparison, there was none receiving a placebo control. The company indicated that a stable platelet response was described as achieving higher than 50,000 platelets per uL of blood on minimum four of the last six scheduled visits between weeks 14 and 24 of treatment.
The company expects results from the second FIT final stage trial in October/November in the current year. The company pointed out the most frequent adverse events of gastrointestinal-related. The product safety profile was consistent with previous clinical experience and that there were no fresh or unusual safety issues were discovered.
Rigel's president and CEO, Raul Rodriguez, said, "These data demonstrate the potential benefit of fostamatinib for chronic ITP patients who are in need of new treatment options. We believe that fostamatinib has significant commercial potential given that it has a unique mechanism of action that may work where other products have failed."
In the pre-market on Tuesday, the stock traded up by $0.30, or 11.36 percent, to $2.94.
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