ABERDEEN, Scotland and SINGAPORE, July 27, 2016 /PRNewswire/ --
Promising Read-Out for First-Ever Tau Aggregation Inhibitor to Enter Phase 3 Trials
- LMTX(R) as monotherapy demonstrates significant reductions in disease progression
in mild and moderate Alzheimer's disease
- Strong results in both cognitive and functional tests supported by brain scan evidence
of slow-down in progression of pathology
- Study misses co-primary endpoints as LMTX(R) as add-on therapy shows no beneficial
- Initial analysis from second phase 3 study in patients with mild Alzheimer's disease
confirm positive findings
TauRx Therapeutics Ltd today announced Phase 3 clinical trial results that show treatment with LMTX(R), the company's novel tau aggregation inhibitor, had a marked beneficial effect on key measures of Alzheimer's disease in patients with mild or moderate forms of the disease.
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While the TRx-237-015 study in 891 subjects failed to meet its co-primary endpoints, clinically meaningful and statistically significant reductions in the rate of disease progression were observed across three key measures in patients who were treated with LMTX (R) as their only Alzheimer's disease medication. These three key measures comprised 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). An abstract of the results will be presented during an open session at the 2016 Alzheimer's Association International Conference (AAIC) in Toronto, Canada this afternoon by Dr. Serge Gauthier, CM, MD, FRCPC, Director of the Alzheimer's Disease Research Unit, McGill University, Canada.
"In a study of this size across a combined mild to moderate patient population, it is both encouraging to see improvements of this magnitude in the standard cognitive and functional tests and reassuring to see the supporting brain scan evidence of a slowing in disease progression during 15 months of treatment," said Dr. Gauthier, "As a practising clinician I see Alzheimer's patients, their families and care-givers every day, and continually share their desperate need for a truly therapeutic product as today we only have symptomatic treatments available to us. In a field that has been plagued by consistent failures of novel drug candidates in late-stage clinical trials and where there has been no practical therapeutic advance for over a decade, I am excited about the promise of LMTX(R) as a potential new treatment option for these patients."
The same efficacy findings were not seen in study patients who took LMTX(R) in combination with other standard Alzheimer's treatments. Since these patients formed the substantial majority of those recruited to the trial, the treatment benefits seen in those taking LMTX(R) as monotherapy could not be seen when all patients taking LMTX(R) were pooled in the primary analysis model. Although this prevented the study from achieving an overall statistical significance in the pooled analysis, the primary analysis model showed a highly significant effect of treatment in the patients taking LMTX(R) as monotherapy. This treatment benefit was confirmed in a prespecified supportive analysis of all of the study's primary and secondary outcomes. This is the first treatment in which a clinical effect has been supported by evidence in delay of progression in brain atrophy shown by MRI scans.
Professor Claude Wischik, Professor of Psychiatric Geratology at Aberdeen University and co-founder of TauRx said, "The results we have seen in this study confirm the results we saw in our Phase 2 study, where an earlier version of the drug was also given as monotherapy. The results we see in those patients not taking Alzheimer's disease medications show the considerable potential of LMTX(R) as a monotherapy for both mild and moderate Alzheimer's disease. Perhaps more importantly, these results support the targeting of the tau tangle pathology in Alzheimer's disease as being a very promising drug development pathway. However, the reason for the observed loss of efficacy of LMTX(R) when taken in combination with currently available treatments for Alzheimer's disease is not as yet understood."
An initial analysis of data from the second of TauRx's two Phase 3 trials in Alzheimer's disease, study TRx-237-005 undertaken in 800 patients with the mild form of the disease, confirms the findings of study TRx-237-015 and supports the potential of LMTX (R) as monotherapy. The results from this study are expected to be published and presented later in 2016.
Impact of LMTX(R) Treatment on Key AD Measures
- The ADAS-cog decline analysis produced highly statistically significant treatment
effects of -6.3 +/-1.4 (p