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news.Myriad Genetics has revealed that Flurizan failed to achieve its goal in a phase II study in mild to moderate Alzheimer's disease. However, a positive trend was observed in mild Alzheimer's disease, suggesting a new area of focus for further trials.
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Patients with mild Alzheimer’s disease who were given the 800mg twice-daily dose of Flurizan demonstrated a 44% slowing of decline in their performance of activities of daily living, as measured by the Alzheimer’s disease cooperative study – activities of daily living inventory (ADCS-ADL).
The 800mg twice-daily drug-treated group with mild disease at baseline demonstrated a 41% slowing of decline during the 12-month study period in global function as measured by the clinical dementia rating – sum of boxes (CDR-sb).
A positive trend was also seen in patients with mild disease on the 800mg twice-daily dose for the primary cognitive endpoint, Alzheimer’s disease assessment scale – cognitive function subscale (ADAS-cog). This group achieved a 29% slowing of cognitive decline.
A further analysis of data from 128 mild Alzheimer’s disease patients indicates that those who achieved the greatest plasma concentrations of Flurizan demonstrated a statistically significant 67% reduction in decline in activities of daily living as measured by ADCS-ADL, compared to patients in the placebo group.
“Even though Flurizan did not achieve significance in the primary endpoints of the phase II Alzheimer’s study, we are encouraged by the statistically significant effect observed in the mild Alzheimer’s disease patients, ” said Peter Meldrum, president of Myriad Genetics.
Based on the phase II results, Myriad Genetics intends to continue its phase III trial, and believes that 800mg twice daily is the preferred dose. Subject to regulatory approval, the company will also consider modifying the phase III protocol to focus future enrollment on mild Alzheimer’s disease patients.