Myriad Genetics progressing with phase III Flurizan study

Flurizan is the first in a new class of investigative drugs known as selective amyloid lowering agents, or SALAs. This mechanism is different from the currently marketed drugs for Alzheimer’s disease that provide only a limited, temporary cognitive boost without affecting the course of the disease itself.

The US phase III trial is the largest placebo-controlled study ever undertaken of an investigational medicine in patients with Alzheimer’s disease, with a total of approximately 1,600 patients enrolled.

Patients enrolled in the study take 800mg twice daily of either Flurizan or placebo and attend periodic physician visits for analysis of their performance on memory, cognition and behavioral tests. The three clinical endpoints of the study are identical to those of the completed phase II trial, in which patients experienced cognitive and behavioral benefit ranging from 34% to 48%.

The US phase III trial is designed with an 18-month study period, although an interim review of the data after 12 months has the potential to halt the trial early if exceptional results are achieved. As was the case with the phase II study, all patients in the US phase III study are permitted to take current standard of care medicines in addition to Flurizan or placebo. Therefore, benefits seen in the trials are over and above any benefit provided by the current standard of care drugs.

“We believe that this trial is very well powered to demonstrate the efficacy of Flurizan in treating Alzheimer’s disease,” said Dr Adrian Hobden, president of Myriad Pharmaceuticals. “We look forward to confirming our belief that Flurizan can help patients with Alzheimer’s disease retain memory and cognition longer and experience fewer psychiatric events.”