Baxter International Inc. (BAX) said results from a late-stage study of its potential treatment for Alzheimer's, immunoglobulin, were negative.
The results didn't meet the co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease.
Baxter--which makes medical products for people with bleeding, kidney and immune disorders, among other conditions--said it will reconsider its current approach for its Alzheimer's program and will determine next steps after full data analyses. Current Baxter studies of immunoglobulin in mild to moderate Alzheimer's disease will be discontinued.
Top-line analyses from the randomized, double-blind, placebo-controlled, multicenter trial found that after 18 months of treatment, patients with mild to moderate Alzheimer's disease taking Baxter's immunoglobulin treatment didn't demonstrate a statistically significant difference in the rate of cognitive decline as compared with placebo. The company also said that results didn't indicate a statistically significant change in functional ability as compared with placebo.
Still, although the study wasn't powered to show statistical significance among the sub-groups, Baxter said in the prespecified subgroup analysis, the 400mg/kg treatment arm showed a positive, numerical difference in change from baseline versus placebo in cognition.
"The study missed its primary endpoints, however we remain interested by the prespecified subgroup 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," said Ludwig Hantson, president of Baxter's BioScience business.
Last month, Baxter reported a slight increase in first-quarter sales, as growth in emerging markets helped to offset continued pricing and utilization pressures in the U.S. and Europe, as well as new austerity measures in China.
Shares fell 2.8% to $68.32 in recent premarket trading. Through Monday's close, the stock has risen 28% in the past 12 months.
Write to Saabira Chaudhuri at saabira.chaudhuri@dowjones.com
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