NEW YORK Neurochem, a biotechnology company, said Monday its Alzheimer's disease treatment candidate failed in a late-stage clinical trial, the Associated Press reported.
Alzhemed (tramiprosate) was found not to be statistically significant in the Phase III clinical trial. The company claimed site variations as complications for the failed study. It did say the drug candidate showed "numerical differences" in the 18-month study.
Neurochem said it already met with the Food and Drug Administration to discuss next steps and statistical models. Though the company said the agency "recognized the difficult issues surrounding a trial of this magnitude … neither the proposed adjusted models nor any further adjustments could be used for this trial to provide results in support of a claim of clinical efficacy."
The results could be used in the future to potentially revise the design of an ongoing European study, according to the Associated Press.
Neurochem said it will continue to study the drug's effectiveness with post-hoc evaluations. It also established a special advisory board to assist the company over the coming months in reviewing and analyzing the data.