Rigel Pharmaceuticals has announced that its Phase II study of fostamatinib in patients with IgA nephropathy has not met its primary endpoints.
The company has released topline data from the proof-of-concept trial that reveals that it did not achieve statistical significance for its primary endpoint, which was mean change in the amount of proteinuria in fostamatinib dose groups compared with placebo.
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IgA nephropathy─also known as Berger’s disease─ is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) lodges in the kidneys resulting in local inflammation that can affect the kidneys’ ability to filter waste from the blood.
Proteinuria refers to the presence of abnormal quantities of protein in the urine, which may indicate damage to the kidneys.
The study evaluated the safety and efficacy as measured by change in proteinuria and renal function. The 76 patients recruited had to have proteinuria greater than 500mg per day and either receive two dosages of fostamatinib or placebo.
Although the primary endpoint for the entire population of the study was not met, a pre-specified subgroup analysis of patients with greater than one gram per day of proteinuria at baseline showed a greater reduction in proteinuria in fostamatinib-treated patients compared with placebo patients. Although this was not statistically significant, Rigel may conduct clinical trials for fostamitinib in this sub-population in the future.
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By GlobalDataRigel president and CEO Raul Rodriguez said: “We find the subgroup analysis encouraging because patients and physicians have been challenged to manage this serious disease that has no approved treatment options. This study has provided valuable information on the potential benefit of fostamatinib in IgA nephropathy patients with significant need, those with greater than one gram/day of proteinuria. We will continue to evaluate the data to determine the best path forward in this indication.”
Rigel plans to seek a pharmaceutical partner to collaborate in the conduct of follow-on clinical studies in IgAN.
The US Food and Drugs Administration (FDA) is set to review the drug for the treatment of idiopathic thrombocytopenic purpura─ a bleeding disorder in which the immune system destroys platelets, which are necessary for normal blood clotting. A verdict from the FDA is due later this month. Fostamatinib is also in Phase II trials for warm antibody autoimmune hemolytic anaemia─a condition in which autoantibodies attach to and destroy red blood cells at temperatures equal to or greater than normal body temperature.
