Rigel Pharmaceuticals Starts Fostamatinib Late Stage Program

Rigel Pharmaceuticals (RIGL) announced that it has commenced a phase III program (n=150) on its pipeline candidate fostamatinib for treating patients suffering from immune thrombocytopenic purpura (ITP.TO), an autoimmune deficiency of the blood. Rigel Pharma intends to evaluate the efficacy of fostamatinib in increasing platelet count in chronic ITP patients through this program.

The program includes two identical multi-center, double-blind, placebo-controlled, 24-week studies involving ITP patients with blood platelet counts consistently below 30,000 per microliter of blood. Rigel Pharma expects results from the program to be available at the end of next year

Rigel Pharma said that 67% of the patient population will be treated with fostamatinib orally (100 mg twice a day). The remaining patients will be treated with placebo (100 mg twice daily). The dosage strength in both the arms will be increased to 150 mg (twice a day) for patients who successfully achieved a certain platelet count and tolerability threshold at week 4 of therapy. The primary endpoint of the program is a stable platelet response by week 24. Platelet counts should be at or above 50,000/microliter of blood for at least 4 of the last 6 qualifying blood draws. We expect investor focus to remain on updates regarding the phase III program on fostamatinib going forward.

We remind investors that Rigel Pharma had partnered with AstraZeneca (AZN) as per a deal inked in 2010. In 2013, the rights to the candidate were returned by AstraZeneca to Rigel Pharma.

Rigel Pharma carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include The Medicines Company (MDCO) and Actelion (ALIOF), each sporting a Zacks Rank #1 (Strong Buy).

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