Flurizan has floundered in an 18-month Phase 3 clinical trial in patients with mild Alzheimer disease. According to a June 30 press release from Myriad Genetics, one of the sponsors of the drug, the study did not achieve statistical significance on either of its primary endpoints—cognition and activities of daily living. The results have prompted the company to discontinue the drug. There is not much more information available on the trial at present, but data are slated to be presented the afternoon of 29 July at the International Conference on Alzheimer’s Disease (ICAD) in Chicago.
Flurizan, the R-enantiomer of the non-steroidal anti-inflammatory, flurbiprofen, is an inhibitor of γ-secretase, the second of two enzymes that cleave amyloid-β (Aβ) from its precursor protein. The hope was that Flurizan would limit production of Aβ and slow or halt disease progression. That strategy may still be valid. “I would attribute the negative Flurizan results to a pharmacodynamic failure: insufficient brain levels to achieve meaningful reduction in Aβ generation,” suggested Paul Aisen, University of California, San Diego, and Director of the Alzheimer’s Disease Cooperative Study (ADCS), in an e-mail to Alzforum. “Though disappointing, the results do not refute the amyloid hypothesis,” he added. Aisen was one of the site investigators on the study when he was at Georgetown University, Washington, DC.—Tom Fagan.