Rember® -- the blue dye that created a stir in 2008 when Phase 2 clinical trial data claimed that it slowed decline in people with Alzheimer's disease -- has now been revamped for Phase 3 testing in another disease, behavioral-variant frontotemporal dementia (bvFTD).
TauRx Therapeutics, a Singaporean-Scottish biotech company, reformulated Rember® to improve absorption and tolerability, and will test its modified oral compound, LMTX, in bvFTD patients at 25 to 30 sites worldwide. Pending ethics review and approvals, the 12-month bvFTD trial is expected to begin enrolling in November or December. The company also plans to launch two Phase 3 trials in AD in late 2012.
The TauRx molecule has roused researchers' curiosity on a number of fronts. It is believed to be the only drug in clinical testing that breaks up aggregates of tau, the protein that forms neurofibrillary tangles in Alzheimer's and other neurodegenerative diseases. Even more unusual, it has reached Phase 3 with hardly any published preclinical data. Aside from several talks and posters presented at the International Conferences on Alzheimer's Disease in Chicago and Vienna, which Alzforum reported in 2008 and 2009, very little data on Rember or LMTX is in the public domain. Moreover, scientists had concerns about the design and analysis of the company's earlier Phase 2 trial in AD, some of which are addressed in the upcoming Phase 3 studies. A recent Alzforum story and Q&A with TauRx CEO Claude Wischik describe these developments.
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