Neurochem starts analyzing Ph III Alzhemed data

Canadian drugmaker Neurochem says that the database for the North American Phase III clinical trial for Alzhemed (tramiprosate) for the treatment of Alzheimer's disease has been locked. The analysis is ongoing and entails employing an accurate statistical model that appropriately describes the data and provides accurate results. Neurochem has been advised by its external team of statisticians that adjustment to the initial statistical model, as set out in the statistical plan, would be necessary to provide accurate results. The firm ntoed that potential changes were discussed with the US Food and Drug Administration before submission and are anticipated in the filed plan.

The company notes that, in a clinical trial of the size, duration and complexity, such a process is not uncommon, and added that it could take several weeks, perhaps longer, before the results are known. However, the firm continues to expect to announce these results during the second quarter of this year.