Rigel: Fostamatinib Meets Primary Endpoint In Phase 3 Study In Chronic ITP

(RTTNews) - Rigel Pharmaceuticals, Inc. (RIGL) announced Tuesday that fostamatinib, its oral spleen tyrosine kinase or SYK inhibitor, met the primary endpoint in the first of two double-blind studies in the FIT Phase 3 clinical program for the treatment of adult chronic/persistent immune thrombocytopenia or ITP.

In pre-market activity on Nasdaq, Rigel shares were gaining 21.21 percent at $3.20.

The study showed that 18% of patients receiving fostamatinib achieved a stable platelet response compared to none receiving a placebo control. The results from the second FIT Phase 3 study are expected in October/November 2016.

Patients who met the primary endpoint of this study typically had an increase in platelet counts to a level above 50,000/uL within the initial weeks of treatment, providing early feedback as to whether it was a viable option for treating their ITP.

The most frequent adverse events were gastrointestinal-related, and the safety profile of the product was consistent with prior clinical experience, and no new or unusual safety issues were discovered.

Raul Rodriguez, president and chief executive officer of Rigel, 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."

If these results are reproduced in the second Phase 3 study and are supported by the results of a planned interim analysis of the Phase 3 extension study, the company expects to submit a New Drug Application with the U.S. Food and Drug Administration in the first quarter of 2017.