Neurochem Releases Results From Tramiprosate North American Trial

Neurochem announced results from the North American Phase III clinical trial designed to assess the safety, efficacy and disease modification effect of Alzhemed (tramiprosate) for the treatment of Alzheimer's disease.

Following a recent meeting with the FDA and subsequent statistical analyses, the company announced that, despite the descriptive data showing numerical differences, the trial for tramiprosate did not demonstrate a statistically significant difference in favor of the drug with respect to the primary endpoints over 18 months of treatment.

A substantial difference observed in hippocampal volume did approach statistical significance, the company said. Due to significant interference from high between-site variations that complicated the statistical analyses beyond expectations, Neurochem said, it is not possible to draw definitive conclusions with respect to the treatment effect of tramiprosate.

Neurochem said it will continue to evaluate the treatment effect of tramiprosate with post-hoc evaluations to facilitate its understanding of the data and assess any treatment effect from the North American trial.