Neurochem announces results from tramiprosate (ALZHEMED) North American Phase III clinical trial
Neurochem Inc. announced top-line results from the North American Phase III clinical trial designed to assess the safety, efficacy and disease modification effect of tramiprosate (ALZHEMED(TM)) for the treatment of Alzheimer's disease (AD). Following a recent meeting with the U.S. food and Drug Administration (FDA) and subsequent statistical analyses, the Company announced that the North American Phase III clinical trial for tramiprosate (ALZHEMED(TM)), despite the descriptive data showing numerical differences, did not demonstrate a statistically significant difference in favor of tramiprosate (ALZHEMED(TM)) with respect to the primary endpoints over 18 months of treatment. However, a substantial difference observed in hippocampal volume did approach statistical significance. Due to significant interference from high between-site variations that complicated the statistical analyses beyond expectations, it is not possible to draw definitive conclusions with respect to the treatment effect of tramiprosate (ALZHEMED(TM)).
At the recent FDA meeting, Neurochem sought feedback on appropriate next steps, especially with respect to the statistical models and the detailed analysis of potential confounding factors. The agency recognized the difficult issues surrounding a trial of this magnitude, with its significant site effect and the large number of covariates identified during the modeling process, and advised that 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 agency recognized that it might be possible to utilize the findings of the North American Phase III study to potentially revise the statistical analysis plan and/or modify the study design of the ongoing European Phase III clinical trial.
Neurochem will continue to evaluate the treatment effect of tramiprosate (ALZHEMED(TM)) with post-hoc evaluations to facilitate its understanding of the data and assess any treatment effect from the North American trial.
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