The initial Phase 3 clinical trial programme involving TauRx’s second-generation tau aggregation inhibitor, LMTX®, comprised two clinical trials (TRX-005 and TRX-015) in Alzheimer’s disease and a further trial (TRX-007) in the neurodegenerative orphan indication behavioural variant frontotemporal dementia (bvFTD). These three studies completed in 2016. The trials failed to meet the primary endpoints for which they were originally designed, but demonstrated promising results which warrant further investigation. TauRx therefore plans to initiate additional clinical studies specifically designed to build on the encouraging data emerging from these Phase 3 trials.

Future research will focus on two areas of particular interest:

  1. In both Alzheimer’s studies, trials TRX-015 and TRX-005, patients taking LMTX® in combination with drugs approved for the symptomatic treatment of Alzheimer’s disease, such as donepezil, rivastigmine, galantamine and memantine (“add-on therapy”) showed no beneficial effects from adding LMTX®, whereas subjects not on these treatments and taking LMTX® (“monotherapy”) demonstrated reductions in the rate of disease progression. While the results shown by the subjects taking LMTX® as monotherapy are encouraging, the trials were not designed to demonstrate this effect and a causative link between monotherapy and clinical benefit must now be established via one or more additional clinical studies.
  2. The control dose used in all three studies appeared to have the same level of activity as the higher doses tested when all are taken as monotherapy. These results suggest that LMTX®, even at a dose as low as 8 mg/day, may be useful. Again, one or more additional studies are required to establish the causal link.

An abstract from the first of TauRx's two Phase 3 trials in Alzheimer’s disease in mild and moderate patients was presented at the 2016 Alzheimer's Association International Conference (AAIC) in Toronto, Canada on 27th July 2016 and results were published in The Lancet in November 2016. 

An abstract from the second Phase 3 trial in Alzheimer’s disease in mild patients only was presented at the 2016 Clinical Trials in Alzheimer’s Disease (CTAD) in San Diego, USA on 8th December. Publication is expected in the first half of 2017.

An abstract from the trial in bvFTD was presented at the 10th International Conference on Frontotemporal Dementias (ICFTD), 31 August-2 September 2016.

To read an interview concerning the Phase 3 results with TauRx’s Executive Chairman and co-Founder, Professor Claude Wischik, please follow this link.

TRx-015 TRx-005  TRx-007