TauRx Therapeutics announced findings from the Phase 3 trial of LMTX for the treatment of mild or moderate Alzheimer’s disease (AD). Results were presented at the 2016 Alzheimer’s Association International Conference (AAIC) in Toronto, Canada.
Study TRx-237-015 was a randomized, double-blind, placebo-controlled Phase 3 trial evaluating the treatment with LMTX for 15 months in 891 patients with mild or moderate Alzheimer’s disease. The study failed to meet its co-primary endpoints as add-on therapy to current AD medications, however, patients treated with LMTX monotherapy showed clinically meaningful and statistically significant reductions in the rate of disease progression across three key measures: a cognitive assessment (ADAS-Cog), a functional assessment (ADCS-ADL) and an assessment of the level of brain atrophy (lateral ventricular volume, LVV, as measured by MRI).
Twice daily treatment with LMTX 75mg or 125mg monotherapy produced highly statistically significant treatment effects of -6.3 +/-1.4 (P<.0001) and -5.8 +/-1.4 (P<.0001) units, respectively, in the ADAS-cog decline analysis. Additionally, the ADCS-ADL decline analysis produced a statistically significant treatment effect of 6.5 +/-1.8 (P=.0013) and 6.9 +/-1.9 (P=.0007) after monotherapy treatment with LMTX 75mg or 125mg, respectively.
A reduction in the rate of brain atrophy progression was also observed with LMTX monotherapy, showing a decrease in the expansion of the LVV by 38%+/-9% (P=.0023) and 33%+/-9% (P=.0014) for 75mg twice a day and 125mg twice a day, respectively, vs. placebo.
LMTX was found to have a tolerable and acceptable safety profile, with overall adverse events similar to those typically seen in other Phase 3 studies for novel AD treatments. The most common adverse events occurred in the gastrointestinal and urinary tracts, and were typically mild and manageable.
LMTX is a novel tau aggregation inhibitor (TAI) designed to undo the tau tangles that cause dementia, thereby slowing and even arresting memory loss.
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