By SHIRLEY S. WANG And JOSEPH WALKER
In the latest disappointment for Alzheimer's research, Baxter International Inc. said Tuesday that a late-stage clinical trial of its antibody medicine, already on the market to treat immune disorders, failed to help patients with the memory-robbing brain disease.
Initial analyses from the 390-patient trial found that after 18 months of treatment, those with mild-to-moderate Alzheimer's disease taking Baxter's intravenous immunoglobulin, or IVIG, drug didn't demonstrate a statistically significant difference in the rate of cognitive decline, compared with a placebo. Data from the randomized, double-blind trial also didn't indicate a benefit in preserving patients' ability to carry out daily activities like eating, bathing and dressing.
"These results argue against IVIG working in the general population of Alzheimer's patients," said Norman Relkin, a neurologist and neuroscientist at Weill Cornell Medical College in New York who led the study and will present the full trial data at the Alzheimer's Association International Conference in July.
As a result, the company decided to stop its other late-stage IVIG trial and will evaluate the future of its Alzheimer's program pending further data analysis, according to Ludwig Hantson, president of Baxter's BioScience business.
Baxter's drug, which is extracted from blood plasma, is marketed as Gammagard in the U.S. and is used to treat primary immunodeficiency, a group of inherited disorders that impede the body's immune system.
The trial's outcome had been eagerly anticipated by many in the Alzheimer's community because earlier, small studies and off-label usage in patients had suggested the medicine might hold promise for treating the disease. Currently the only drugs on the market for the condition improve symptoms for a limited amount of time; they don't slow or halt disease progress.
Instead, the trial became yet another setback in the search for a more effective therapy. There is a growing pile of late-stage experimental drug failures, most notably two monoclonal antibodies, Pfizer Inc.'s and Johnson & Johnson's bapineuzumab and Eli Lilly & Co.'s solanezumab. Pfizer and J&J have closed their bapineuzumab program. Lilly is still debating whether to continue developing its compound.
With IVIG, it is possible that there might be subgroups of patients for whom it would be effective, said Dr. Relkin. Preliminary secondary analyses suggested that patients with moderate levels of the disease, or those who carry a genetic risk factor, may benefit.
However, it is unclear why the treatment may work in patients with more severe disease. The typical thinking among experts is that drugs are likely to be more effective earlier on in the disease.
Some research analysts were skeptical of the results and said they doubted that the benefit signal would hold up on further analysis and prompt Baxter to conduct further clinical studies.
"When you speak to those doctors, they say the benefit was clearest in mild patients—that's why we were surprised to see a benefit in moderate patients," said Glenn Novarro, an RBC Capital Markets analyst. "We look at the results as random."
Baxter shares fell 3.5% to $67.87 in midday trading Tuesday on the New York Stock Exchange.
—Saabira Chaudhuri contributed to this article.
Write to Shirley S. Wang at shirley.wang@wsj.com and Joseph Walker at joseph.walker@dowjones.com
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