Myriad Genetics completes enrollment in Flurizan trial for Alzheimer's disease

By E. Janene Geiss

Philadelphia, Aug. 22 - Myriad Genetics, Inc. announced Tuesday that it has completed enrollment in its U.S. phase 3 clinical trial of Flurizan for patients with Alzheimer's disease.

The trial is the largest placebo-controlled study ever undertaken of an investigational medicine in patients with Alzheimer's disease, with a total of about 1,600 patients enrolled, according to a company news release.

Patients enrolled in the study take 800 mg twice daily of either Flurizan or a 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 2 trial in which patients experienced cognitive and behavioral benefit ranging from 34% to 48%, officials said.

Two of the three endpoints were statistically significant in the phase 2 study.

The phase 3 trial in the United States is designed with an 18-month study period; however, an interim review of the data after 12 months has the potential to halt the trial early if exceptional results are achieved, officials said.

As was the case with the phase 2 study, all patients in the U.S. phase 3 study are permitted to take current standard-of-care medicines in addition to Flurizan or a placebo. Therefore, benefits seen in the trials are over and above any benefit provided by the current standard-of-care drugs.

Encouraging data from the phase 2 study, and a total of more than 600 patient-years of data with Flurizan, led Myriad to continue accelerated development of Flurizan and to recently begin a European phase 3 trial that will study about 800 patients with mild Alzheimer's disease.

The Flurizan phase 2 study is the only controlled, blinded study of a drug added to current treatments, either on the market or in clinical development, to show continued statistically significant benefit in Alzheimer's disease patients over a period of more than 12 months, the company said.

The company said it believes that this is due to the mechanism of action of Flurizan in addressing the underlying cause of Alzheimer's disease.

Flurizan is the first in a new class of investigative drugs known as Selective Amyloid Lowering Agents (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. Flurizan is not an Nsaid and does not inhibit COX1 or COX2 enzymes.

With a safety database consisting of more than 600 patient-years of exposure data, Myriad said it has not seen gastrointestinal toxicity attributable to Flurizan.

The phase 2 study of Flurizan showed that patients taking 800 mg twice daily continued to benefit over 24 months in tests of memory loss, cognition and behavior. In addition, those on Flurizan had fewer psychiatric events such as aggression, depression, confusion and agitation, officials said.

Not only were there fewer psychiatric events among patients on Flurizan, but also the average time before a patient experienced such an event was significantly longer. This is an important finding for both patients and caregivers because these types of events are often difficult for caregivers and a frequent reason for transitioning the patient to a nursing care facility, the company said.

By delaying the time at which a patient must enter a care facility, Myriad said it believes there is potential for significant savings in the overall cost of the disease.

Myriad is a Salt Lake City biopharmaceutical company.

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