TauRx Therapeutics Ltd. started enrolling patients in the U.S. for two late-stage clinical trials to test an experimental treatment for mild to moderate Alzheimer’s disease.
The drug, LMTX, targets tangles of tau protein in the brain, dissolving them to halt their harmful effects on memory, closely held TauRx said in a statement today. LMTX also works on precursors to fully formed tau tangles, the Singapore-based company said. The trials, part of the last of three phases of human testing usually needed for regulatory approval, will involve more than 1,300 people in more than a dozen countries.
The tangles in the brain were first reported by Dr. Alois Alzheimer in 1907. It wasn’t until the 1990s that evidence began to accumulate that tau deposits more closely reflected a patient’s mental state than beta amyloid plaques, proteins that are targeted by drugs such as bapineuzumab developed by Johnson & Johnson (JNJ) and Pfizer Inc. (PFE) TauRx Chairman Claude Wischik has been studying the tau approach for three decades as professor of old age psychiatry at the University of Aberdeen in Scotland, where the company has its main research facilities.
“The field has been dominated by the amyloid hypothesis,” Wischik said in a webcast presentation today. “But I expect that to change over time. It really is time to test the role of tau.”
LMTX is an altered version of an earlier experimental product called Rember, a form of the dye methylene blue. Data from mid-stage clinical trials of Rember, announced in 2008, showed about a 90 percent reduction in the rate of disease progression over two years. Detailed results from the studies will be published next year, Wischik said.
New research is showing that while beta amyloid is part of the disease process, it may not be the root cause of Alzheimer’s or the only target for treatment, said Maria Carrillo, vice president of medical and scientific affairs at the Chicago-based Alzheimer’s Association.
“We need multiple approaches to Alzheimer’s,” Carrillo said in a phone interview. “The field has been shifting to look at alternative strategies, and it’s very encouraging that TauRx is confident enough to move into phase 3 trials.”
While the Alzheimer’s Association isn’t funding TauRx, it supports research at non-profit institutions studying amyloid-, tau- and inflammation-based approaches, among others, Carrillo said.
Patients interested in participating in TauRx’s clinical trials may find information on the closest hospital to contact on the company’s website, Wischik said.
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