TauRx Therapeutics begins Phase 3 clinical trial in early form of dementia
TauRx Therapeutics announced the initiation of a global Phase 3 clinical trial in a type of Frontotemporal dementia (FTD) also known as Pick’s Disease. The study focuses on a type of FTD known as behavioural-variant, or bvFTD, which can cause early changes in personality and loss of empathy. A large percentage of these patients have a specific pathology that involves abnormal collections of tau protein in the brain.
The study drug, LMTX®, targets a process in the brain whereby a normal form of tau protein begins to self-aggregate due to binding neuronal waste-products. Once the process has started, the aggregates are able to propagate themselves indefinitely, using up normal tau protein and converting it into the toxic aggregates. After destroying the nerve cells where they are initially formed, the aggregates go on to infect nearby healthy neurons, progressively spreading and accelerating the destruction throughout the brain. LMTX® stops this aggregation process in its tracks and releases the trapped tau protein in a form which can be easily cleared by nerve cells.
In a pilot series of cases, LMTX® was found to arrest the progression of the disease. LMTX® has been found to act in a similar way on the aggregation of TDP-43 protein. Tau or TDP-43 aggregates each account for about 50% of patients with this early form of dementia.
The Phase 3 double-blind placebo-controlled study is designed to evaluate the safety and efficacy of LMTX®, the second-generation Tau Aggregation Inhibitor (TAI) developed by TauRx. The study aims to confirm the results first seen in the pilot cases in a larger controlled clinical trial in bvFTD patients over a 52-week timeframe. Participating study sites are located in Canada, U.S., U.K., Germany, The Netherlands, Australia and Singapore. Because the condition is relatively rare, TauRx was granted Orphan Designation for LMTX® in 2010, which provides a basis for more rapid approval for marketing if the trial is successful.
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