Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) announced that data from its Phase II clinical trial of fostamatinib for adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) would be in the American Journal of Hematology.
The data indicate that fostamatinib significantly increased hemoglobin in about 50% of the volunteers. It also reported positively on the drug’s tolerability and safety.
According to the CEO and President of the company, Raul Rodriguez, wAIHA is a rare blood disease that fostamatinib could treat. Moreover, the Food and Drug Administration (FDA) has not approved any therapy to treat the disease. For this reason, Rigel hopes that fostamatinib could be first. It hopes to get approval for the drug by 2023. The disease could be the second indication for fostamatinib.
Patients responded positively to the treatment
The trial looked into patients’ response to a twice-daily dose of 150mg BID fostamatinib. The patients researchers used had not responded to one treatment and had active hemolysis of lower than 10g/dL.
Results indicated that the patients’ response to the drug was positive. The researchers noted a few side effects, such as insomnia (23%), dizziness (27%), hypertension (27%), fatigue (42%), and diarrhea (42%). Fortunately, they had an easy time managing these symptoms.
Rigel Pharmaceuticals is currently considering a Phase III placebo-controlled, double-blind, randomized clinical trial. The researchers have gathered 90 wAIHA patients who failed treatment.
The company markets the drug as fostamatinib
The trial’s objective is to investigate if the drug could produce a higher and more consistent hemoglobin response of greater than 10g/dL than the placebo. Meanwhile, the drug has received Fast Track and Orphan drug designations from the FDA to treat wAIHA.
Rigel already markets fostamatinib as TAVALISSE tablets. The drug treats thrombocytopenia in patients dealing with chronic ITP. It is marketed towards patients who did not significantly respond to other medication.
The side effects of TAVALISSE include hypertension, diarrhea, and neutropenia. For this reason, care should be taken when administering to patients with hypertension. In addition, physicians should monitor patients who receive TAVALISSE to minimize adverse effects. The drug is also harmful in pregnant and breastfeeding women. Physicians should also take caution with women using contraceptives.
