Scientific Basis for LMTX™ in Frontotemporal Dementia
Professor Wischik and colleagues have spent nearly 30 years investigating the structure and role of Tau tangles in the development of Alzheimer’s disease, frontotemporal dementia (FTD) and other neurodegenerative diseases. They were the original discoverers of the Tau protein pathology of Alzheimer’s.
Because bvFTD 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. The investigational drug had been previously tested in a small open-label pilot study involving a small number of patients, with encouraging results, leading the company to pursue approval by U.S. and E.U. regulatory authorities to advance to an international Phase 3 clinical trial of LMTX™ in bvFTD.
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.
TauRx previously tested rember®, the first-generation TAI on which LMTX™ is based, in a Phase 2 clinical trial involving 321 patients with mild and moderate Alzheimer’s Disease in the UK and Singapore. This study found a 90% reduction in the rate of disease progression over two years in Alzheimer’s.