Myriad Genetics, Inc. has completed enrolment in its US phase 3 clinical trial of Flurizan for patients with Alzheimer's disease.
The US phase 3 trials 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 800 mg twice daily of either Flurizan or placebo and attend periodic physician visits for analysis of their performance on memory, cognition and behavioural tests. The three clinical endpoints of the study are identical to those of the completed phase 2 trials, in which patient's experienced cognitive and behavioural benefit ranging from 34 per cent to 48 per cent two of the three endpoints were statistically significant in the phase 2 studies. The US phase 3 trials 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.
As was the case with the phase 2 studies, all patients in the US phase 3 studies 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.
Encouraging data from the phase 2 studies, and a total of over 600 patient-years of data with Flurizan, led Myriad to continue accelerated development of Flurizan and to recently initiate a European phase 3 trials that will study approximately 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 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 over 600 patient-years of exposure data, Myriad has not seen gastrointestinal toxicity attributable to Flurizan.
"We believe that this trial is very well powered to demonstrate the efficacy of Flurizan in treating Alzheimer's disease," said Adrian Hobden, PhD, President of Myriad Pharmaceuticals, Inc. "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, through this large, well-controlled phase 3 study."
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 a fewer psychiatric events such as aggression, depression, confusion and agitation. 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.
Myriad Genetics, Inc. is a biopharmaceutical company focused on the development of novel healthcare products. The company develops and markets molecular diagnostic products, and is developing and intends to market therapeutic products.