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news.Neurochem has reported disappointing top-line results from its Phase III clinical trial designed to assess the safety, efficacy and disease modification effect of Alzhamed for the treatment of Alzheimer's disease.
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Following a meeting with the FDA and subsequent statistical analyses, the company reported that despite the descriptive data showing numerical differences, the drug did not demonstrate a statistically significant difference in favor of Alzhamed with respect to the primary endpoints over 18 months of treatment.
Due to significant interference from high between-site variations that complicated the statistical analyses beyond expectations, Neurochem says it is not possible to draw definitive conclusions with respect to the treatment of Alzhamed.
At the recent FDA meeting, the company says it sought feedback on appropriate next steps, especially with respect to the statistical models and the detailed analysis of potential confounding factors. Neurochem says 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.
Neurochem says it will continue to evaluate the treatment effect of the drug.