Results of trial of LMTX in Alzheimer's Disease published-TauRx Therapeutics

The Journal of Alzheimer's Disease has published the results of the first clinical trial of LMTX, a Tau Aggregation Inhibitor (TAI) in Alzheimer's disease (AD). This Phase II clinical trial, conducted by TauRx Therapeutics provided the basis and rationale for subsequent Phase III clinical trials of a TAI in AD currently in progress. The double-blind dose-finding Phase II clinical trial involved 321 patients in 16 clinical research centres in the UK and one centre in Singapore and tested three doses of the drug. The study met its predefined primary efficacy endpoint at 24 weeks on the standard scale most commonly used to measure cognitive decline in clinical trials (ADAS-cog) at the 138 mg / day dose.

The primary result was also supported by benefit on two other clinical scales. The effect sizes seen were statistically significant and clinically meaningful in moderate subjects at 24 weeks. The clinical results were also supported by brain scan evidence of arrest of decline over the same period in mild subjects at the same dose. The beneficial effect was sustained to 50 weeks in both mild and moderate subjects at this dose, with 90% reduction in the rate of cognitive decline overall.

The full results now published in the Journal of Alzheimer's Disease were previously available only as reports supporting regulatory filings for global confirmatory Phase III clinical trials in 22 countries. These trials are now fully recruited and the first results are expected in the first half of 2016. If the Phase III clinical trials confirm a level of efficacy and safety similar to that seen in the Phase II trial reported in the Journal of Alzheimer's Disease, a treatment targeting the Tau aggregation pathology of AD could be on the market as early as 2017.