Baxter Alzheimer’s drug fails to meet phase 3 endpoints

Baxter International Inc has announced that its phase 3 clinical trials of immunoglobulin (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.

Baxter has decided to discontinue these clinical trials, known as the Gammaglobulin Alzheimer's Partnership (GAP) study, and will determine its next steps after a full data analysis.

The study was being conducted in collaboration with the Alzheimer's Disease Cooperative Study (ADCS), a clinical trial consortium supported by the United States National Institute on Aging in the National Institutes of Health.

Results showed that after 18 months of treatment, patients with mild to moderate Alzheimer's disease taking Baxter's IG treatment failed to demonstrate a statistically significant difference in the rate of cognitive decline as compared to placebo.

"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. We are grateful for the participation of the patients and physicians in the study and for the dedicated support of the patients' caregivers."

Ludwig Hantson, Ph.D., president of Baxter's BioScience business.

Alzheimer's disease is the most common type of dementia and more than five million people live with the disease today. There are currently no licensed drugs to slow the progression of Alzheimer's, current approved medications only treat symptoms.