Singapore-based TauRX is progressing its experimental medicine known as “LMTM” to advanced Phase III clinical trials in America and Europe based on the results of two previous Phase III studies evidencing the potential promise as a treatment for Alzheimer’s disease.
What is LMTM?
Officially known as hydromethylation, (LMTM or TRx 0237) originates from methylene blue dye and claims to slow cognitive decline by stopping the buildup of tau protein in the brain. TauRX positions LMTM as different from amyloid drugs, which target amyloid plaques and haven’t yielded actional results.
It is a second-generation tau protein aggregation inhibitor for the treatment of Alzheimer’s disease and frontotemporal dementia. It is a replacement formulation for the Rember®, the first company’s first proprietary formulation of methylthioninium chloride (MTC), reports AlzForum.
LMTM is not without controversy. Data from previous studies hasn’t led to strong enough evidence to support a hypothesis that it works and many are skeptical.
This experimental drug has been led primarily by Dr. Claude Wischik, Chairman of TauRx and a professor of psychiatric gerontology at the University of Aberdeen, Scotland–who has worked on the compound for about a decade.
Previous Studies Failed
At 100 milligrams dosage back in 2016, two previous clinical trials failed to product any material results for patients with mild-to-moderate Alzheimer’s disease.
However during those 2016 trials the investigators focused in on a subset of the control group, who had been given a low dose of four milligrams. The investigators observed that form this low dose the experimental therapy may actually have been effective after all. However, the low dose seemed to only be effective when the patients were not consuming any other symptomatic Alzheimer’s medications such as Aricept.
Of course, the critics came out in full force. After all, they positioned, the current researchers had to dig deep into the data to search for and spin data in a positive light.
Not giving Up
Dr. Wischik won’t give up. He continues the full-court press based on the results he held up from the last two clinical trials.
Results from Latest Study
Based on the latest results, researchers utilized the same data from 1,162 participants from previous Phase III clinical trials but is analyzing such data in a different way. This time the team measured blood levels of the drug and their impact on the brain and came to the summary that a low dose of 16 milligrams revealed an effective dose in treating patients with mild-to-moderate Alzheimer’s disease, reports Being Patient.
New Clinical Trials
Despite the skepticism and controversy Wischik is a believer and will forge ahead to plan new clinical trials for LMTM. The next study design will include a placebo-controlled trial with 450 participants in a quest to prove the drug works at 16 milligrams. The study is already in recruitment mode and will be conducted across 150 sites in America and Europe. Recruitment starts this month in America and in Europe 2020.
The Study is listed in Clinicaltrials.gov as an Expanded Access Program but much information is excluded including dates, sites, etc.
About TauRX Therapeutics Ltd
Founded in 2002, TauRx has raised over $250 million in private equity capital. The venture was established in Singapore in 2002 with the aim of developing new treatments and diagnostics for a range of neurodegenerative diseases based on an entirely new approach, which targets aggregates of abnormal fibers of Tau protein that form inside nerve cells in the brain. The TauRx team have since discovered that LMTX™ could also have beneficial effects in several other neurodegenerative diseases associated with Tau pathology, as well as other protein aggregation disorders including Parkinson’s, Huntington’s and Frontotemporal Dementia (Pick’s Disease). While TauRx headquarters are in Singapore, its primary research facilities are in Aberdeen, Scotland.