Myriad says Flurizan study demonstrates significant benefit in Alzheimer's disease patients

By E. Janene Geiss

Philadelphia, July 19 - Myriad Genetics, Inc. announced Wednesday that results of its completed phase 2 follow-on study of Flurizan in patients with mild Alzheimer's disease suggest that patients taking 800 mg twice a day had a substantial benefit over other dose groups and this benefit continued to increase over 24 months for cognition, memory loss, global function and activities of daily living.

The data also suggest that during the follow-on period from months 12 to 24, the benefit of Flurizan increases in terms of both effect size and significance, the longer patients remain on Flurizan, according to a company news release.

At month 24, patients taking 800 mg of Flurizan twice daily had an effect size of 72%, with a highly significant value of p=0.0005, as measured by their global function on the CDR-sb test.

In terms of the performance of activities of daily living at 24 months, the patients showed a 67% effect size, with a value of p=0.015, which also is significant, officials said.

Flurizan is improving the rate of cognitive decline also, as shown by the effect size of 52% at 24 months on the ADAS-cog scale, officials said.

These data suggest that there was a substantial benefit from Flurizan on activities of daily living and global function, and that the benefit was increasing over time.

The vast majority (94%) of patients in this phase 2 study, at the time of enrollment, were receiving stable doses of acetylcholinesterase inhibitors, FDA-approved drugs for symptomatic treatment of Alzheimer's disease.

Thus, the benefits of Flurizan observed in these patients were over and above the current standard of care.

Importantly, the phase 2 trial also studied the occurrence and timing of serious psychiatric events in patients with Alzheimer's disease.

The occurrence of psychiatric problems such as agitation, aggression, confusional state and depression was monitored throughout the study. Over the 12-month study, about 35% of participants taking a placebo experienced such an event.

However, patients on 800 mg twice daily Flurizan experienced a 60% reduction in psychiatric events compared to those on a placebo and the time to such an event was significantly longer with patients on Flurizan than those on a placebo, officials said.

These data provide an indication that their disease had progressed more slowly than those on a placebo.

After completion of Myriad's 12-month phase 2 trial of Flurizan, study participants who had previously received a placebo during the phase 2 trial were randomized into the 400 mg twice daily group or the 800 mg twice daily group.

In this "randomized start" design, former placebo patients were then followed for an additional 12 months.

Results from this analysis indicate that patients treated with 800 mg twice daily of Flurizan for 24 months decline more slowly with regard to cognition, activities of daily living and global function than those treated with the same dose for just 12 months in the follow-on study, officials said.

Additionally, those former placebo patients who were randomized onto 800 mg Flurizan twice daily declined more slowly than those randomized onto 400 mg on both the ADAS-cog and the CDR-sb measures of disease progression.

The results were presented at the 10th International Conference on Alzheimer's Disease and Related Disorders in Madrid, Spain.

Myriad said it has begun to enroll a phase 3 trial in patients with mild Alzheimer's disease including investigators in Italy, France, Germany, Spain, Sweden, Switzerland, United Kingdom, Netherlands, United States, Belgium, Canada and Denmark.

The trial will enroll about 800 participants into two groups, 800 mg twice daily and a placebo, and the participants will receive treatment for 18 months.

Myriad said it also is enrolling patients with mild Alzheimer's disease into a phase 3 trial at 130 centers across the United States. This enrollment is well advanced and is expected to be complete this summer.

The phase 3 trial is a double blind, placebo-controlled trial with patients randomized into one of two groups, receiving either 800 mg of Flurizan or a placebo twice daily for the duration of the 18-month trial.

The study is designed to determine Flurizan's ability to reduce the rate of cognitive decline and activities of daily living in patients with mild Alzheimer's disease, as measured by ADAS-cog and ADCS-ADL, respectively.

Myriad is a Salt Lake City biopharmaceutical company.

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