Baxter International Inc. (BAX) Tuesday said its Phase III clinical study of immunoglobulin or IG did not meet its co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease.
The company said topline analyses from the trial found that after 18 months of treatment, patients taking the IG treatment at either the 400 mg/kg or the 200 mg/kg dose did not demonstrate a statistically significant difference in the rate of cognitive decline as compared to placebo.The company further said that results also did not indicate a statistically significant change in functional ability as compared to placebo.
Commenting on the development, Ludwig Hantson, president of Baxter's BioScience business said, "''The study missed its primary endpoints, however we remain interested by the pre-specified sub-group analyses, particularly among patients with moderate disease and those who carry a genetic risk factor for Alzheimer's disease, two patient groups that are in great need of advances in care. A detailed analysis of the results from the GAP study continues, and we look forward to a greater understanding of the full data set..."
Pursuant to these results, Baxter is expected to reconsider its current approach for the Alzheimer's program and determine next steps after full data analyses. The firm's current studies of IG in mild to moderate Alzheimer's disease are expected to be discontinued.
The Gammaglobulin Alzheimer's Partnersh or GAP study was the largest placebo-controlled study of immunoglobulin, and was designed to assess the safety and effectiveness of Baxter's IG as a potential treatment for signs and symptoms associated with Alzheimer's disease, said the company. The clinical trial treated 390 patients with mild to moderate Alzheimer's disease across 45 centers in the U.S. and Canada.
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