TauRx’s tau aggregation inhibitors (TAIs) are the product of nearly 30 years of research, preclinical and clinical investigations. The company’s first-generation TAI, rember®, is a patented, highly-purified version of methylene blue, a compound previously used to treat a variety of conditions.
The TauRx team reported encouraging Phase 2 clinical trial results with rember®, providing strong support for the tau hypothesis and adding to the well-established correlations confirmed by many groups linking the spread of tau aggregation pathology with clinical dementia from its earliest detectable stages. The findings suggested that a treatment targeting the tau aggregation cascade could potentially delay the progression of cognitive decline in mild to moderate Alzheimer’s.
These findings were tested in Phase 3 clinical trials, now completed, with the company’s second generation TAI, LMTX®. The clinical trial programme involved over 1,900 patients and comprised three separate trials: two in Alzheimer's disease and one in the rare neurodegenerative disorder, behavioural variant frontotemporal dementia.
An abstract from the first of its two Phase 3 trials in Alzheimer’s disease was presented at the 2016 Alzheimer's Association International Conference (AAIC) in Toronto, Canada on 27th July and results were published in The Lancet in November 2016.
An abstract from the second of the two Phase 3 studies in Alzheimer’s disease, in mild patients only, was presented at the 9th Clinical Trials on Alzheimer’s Disease (CTAD) on 8th December 2016. Publication is expected shortly after this.
Results for the Phase 3 trial in behavioural variant frontotemporal dementia (bvFTD) were reported for the first time at the 10th International Conference on Frontotemporal Dementias (ICFTD), 31 August-2 September 2016.
Only when all Phase 3 study results have been analysed and discussed with regulatory authorities will TauRx be able to decide on the further development of LMTX® as a treatment for mild or moderate Alzheimer’s disease and behavioural variant frontotemporal dementia (bvFTD).