Neurochem’s independent safety review board (ISRB) for Alzhemed is made up of independent medical experts who monitor and evaluate the safety of patients taking part in the Alzhemed phase III trial.
The recommendation by the ISRB members was based on their recent review of the safety data from 562 patients who have been monitored in the trial for at least 12 weeks so far. After reviewing the safety information, the ISRB concluded that there were no significant safety concerns to report in the study and that the trial should continue as planned.
As part of a “disease modifying” novel class of product candidates, Alzhemed is expected to act at two levels: in preventing and stopping the formation and the deposition of amyloid fibrils in the brain and in binding to soluble A(B) protein to reduce the amyloid-induced toxicity on neuronal and brain inflammatory cells associated with amyloid build-up in AD.
Neurochem anticipates launching a phase III trial for Alzhemed in Europe later this year.