Flurizan Phase II trial shows no overall benefit
A recently completed Phase II trial shows that treatment with R-flurbiprofen (Flurizan) did not help individuals with mild or moderate Alzheimer's disease when results for all 207 participants were considered as a whole, according to a report from Myriad Pharmaceuticals, the drug's developer.
However, the company says it saw some encouraging signs when data for just the 128 participants with mild Alzheimer's were analyzed separately. Based on these preliminary results, Myriad plans to move forward with a Phase III trial and is recruiting participants throughout the United States.
"We are pleased to hear that Myriad is sufficiently encouraged to go ahead with the Phase III trial," says William H. Thies, Ph.D., Alzheimer's Association vice president, medical and scientific affairs. "R-flurbiprofen theoretically works by modifying beta-amyloid processing in a different way than most other drugs currently in clinical trials. It would be a worthwhile contribution to clinical knowledge to see how this drug performs in a larger trial designed to explore some of the early signs Myriad sees in their data. The company will be discussing more details about their Phase II results at the Alzheimer's Association International Conference on Prevention of Dementia in June, where scientists not connected with the company will have an opportunity to comment on the trial's findings."
According to Myriad, the Phase II participants with mild Alzheimer's who were taking the highest experimental dose of R-flurbiprofen showed a tendency to do better than those receiving the placebo on tests of memory and thinking skills, ability to carry out daily activities and overall function. However, those benefits did not meet statistical criteria for having a high likelihood of being due to the effects of the drug rather than to chance.
The company then further subdivided the data to focus on participants with mild Alzheimer's taking the highest dose who also developed high levels of the drug in their bloodstream. That group experienced a statistically significant benefit in their ability to carry out daily activities and their overall function, but not on measures of memory and thinking skills.
Flurbiprofen is one of a handful of nonsteroidal anti-inflammatory drugs (NSAIDs) shown in laboratory and animal studies to reduce levels of beta-amyloid, a protein fragment considered a prime suspect in Alzheimer's disease. Generic flurbiprofen is a mixture of "R" and "S" molecules whose structures are mirror images of one another. Myriad's Flurizan, also known by the investigational name MPC-7869, contains only R-flurbiprofen, the form that seems to have the greatest impact on beta-amyloid but has little or no anti-inflammatory effect. The anti-inflammatory effects of NSAIDs are associated with certain serious side effects, including bleeding in the stomach and intestines and increased risk of heart attack and stroke.
For more information, please see:
- Details about the new Phase III trial of Flurizan at ClinicalTrials.gov
- A Jan. 19, 2005, Research News feature on the Phase III Flurizan trial
- An Aug. 5, 2003, Research News feature on R-flurbiprofen
- The Alzheimer's Association fact sheet on the "amyloid hypothesis" and drugs targeting beta-amyloid
- The Alzheimer's Association fact sheet on anti-inflammatory drugs