ABERDEEN, Scotland and SINGAPORE, November 27, 2017 /PRNewswire/ —
TauRx Therapeutics Ltd today reported the full results from its second Phase 3 clinical study of LMTX®, the first tau aggregation inhibitor in Alzheimer’s disease, published online in the Journal of Alzheimer’s Disease.
Results from this study (TRx-237-005) are consistent with those from the first Phase 3 study, recently published in The Lancet [(TRx-237-015) Gauthier et al. 2016] in mild to moderate Alzheimer’s disease, in supporting the hypothesis that LMTX® might be effective as monotherapy at a dose as low as 4 mg twice daily.
The latest study (TRx-237-005) investigated the efficacy and safety of LMTX® in 800 patients with mild Alzheimer’s disease at a dose of either 100 mg or 4 mg (intended as the control dose) twice daily over an 18-month treatment period.
The results of the earlier study showed significant differences in favour of two higher doses of LMTX® (75 mg and 125 mg twice daily) when taken as monotherapy compared with the intended 4 mg control dose taken as monotherapy or as add-on therapy to currently approved treatments for Alzheimer’s disease in pre-specified post hoc analyses. In a further analysis, the same difference in favour of monotherapy compared with add-on treatment was found in patients taking the 4 mg twice daily dose.
Therefore, prior to database lock and unblinding, the primary analyses of TRx-237-005 were modified to compare 100 mg LMTX® twice daily as monotherapy with the intended control, and 4 mg twice daily as monotherapy compared with the same dose as add-on therapy as non-randomised cohort analyses. The aim was to test whether the findings from the first study could be confirmed as primary outcomes in a second independent study with strong controls against statistical error.
Results of the second study showed the same significant differences in favour of LMTX® monotherapy at the required statistical threshold of p < 0.025 in both comparisons on the co-primary clinical efficacy endpoints for the cognitive (ADAS-cog) and functional (ADCS-ADL) outcomes.
In both the LMTX® monotherapy and add-on therapy groups, whole brain atrophy (measured via MRI scans) initially progressed as expected for patients with mild Alzheimer’s disease. However, after 9 months of treatment, the annualised rate of whole brain atrophy in monotherapy patients reduced significantly and became typical of that reported in normal elderly controls without Alzheimer’s disease. The comparable rate seen in the add-on therapy group progressed as reported for patients with mild