Baxter's Gammagard fails in Phase III AD trial

Baxter International Inc. (NYSE:BAX) said both 200 and 400 mg/kg doses of IV Gammagard Liquid 10% given every two weeks missed the co-primary endpoints in the 390-patient Phase III GAP trial (Study 160701) to treat mild to moderate Alzheimer's disease (AD). Both low- and high-dose Gammagard did not reduce functional decline as measured by Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) scores and did not preserve functional abilities as measured by Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scores from baseline to 18 months vs. placebo (p>0.1 for all). The trial was conducted in collaboration with the Alzheimer's Disease Cooperative Study (ADCS), a clinical trial consortium supported by NIH's National Institute on Aging.

Baxter said it will determine next steps after it completes a full data analysis, but said it will discontinue ongoing trials of Gammagard in mild to moderate AD. The company also said it will continue to analyze biomarker data to determine if there is any correlation with the numerically positive cognition data from the subgroups of patients with moderate AD or carriers of the apolipoprotein E epsilon 4 (APOE4) genotype. ...