Baxter International said it was ending clinical trials for Gammagard, a treatment for Alzheimer’s disease that once showed great potential.
“The study missed its primary endpoints,” Ludwig Hantson, Baxter’s head of bioscience said in a statement.
“We are currently re-evaluating our approach,” Hantson told reporters on a conference call. “There is a lot of hypothesis but there are a lot of question marks here as well.”
According to the pharmaceutical company, trial patients with a moderate form of Alzheimer’s and those with a genetic mutation that increased risk of the disease didn’t see enough of a benefit for scientists to conclude that the drug was more effective than a placebo.
The study included about 390 patients and was expected to find that the treatment helped to reduce beta-amyloid plaques, which are associated with Alzheimer’s and other similar neurological diseases. Earlier trials had shown the drug stabilized Alzheimer’s in four patients over the course of three years.
Hantson said that the company is still combing through the data from the 18-month trial and there were indications that higher doses of drug might benefit patients with a moderate form of disease and in patients with a gene variant called ApoE4.
He added that Baxter wanted to analyze data it did not yet have access to, including brain atrophy information recorded by MRI scans and the levels of amyloid proteins in the blood and spinal fluid. Depending on the analysis of these results, the company could decide to start new trials for some categories of patients and the company said it will make a decision about moving forward with trials of the drug by the end of the year.
Drug already approved by the FDA
Gammagard is already available to take care of certain blood conditions, and therefore already approved by the FDA for that particular use. The drug is designed to boost the immune system and is derived from antibodies found within health blood donations. The treatment, also known as intravenous immunoglobulin (IVIG), is often used to bring down infections in patients with compromised immune systems.