LMTX fails Phase III trial, monotherapy benefits seen
pharmafile | July 28, 2016 | News story | Research and Development | Alzheimer's, LMTX, TauRX, phase III, phase III failure
TauRX Therapeutics has reported Phase III clinical trial results for its novel tau aggregation inhibitor LMTX. The results indicated that the TRx-237-015 study of 891 participants failed to hit its co-primary endpoints, though reductions in the rate of disease progression in mild to moderate iterations of Alzheimer’s were noted in participants who were treated with LMTX as their only medication for the illness.
These results were observed across three key measures, including 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). Patients who used LMTX in conjunction with other standard Alzheimer’s treatments did not see comparable benefits.
The treatment’s proposed benefit as monotherapy was corroborated in a prespecified supportive analysis of all of the study’s primary and secondary outcomes. The treatment is the first in which a clinical effect has been supported by evidence in delay of progression in brain atrophy shown by MRI scans.
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 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 when taken in combination with currently available treatments for Alzheimer’s disease is not as yet understood.”
Matt Fellows
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