2023-07-16 19:27:00
Groundbreaking Study Shows Promising Results for Alzheimer’s Treatment
ABERDEEN, Scotland – TauRx Pharmaceuticals Ltd., a global leader in tau-based research in Alzheimer’s disease (AD), has announced results from a Phase 3 study called LUCIDITY, which highlights the positive effects of the drug HMTM on neurofilament light chain (NfL) – a biomarker of neurodegeneration in the brain.
The study, which measured the change in NfL levels over 12 months, found that participants receiving a dose of 16 mg/day of HMTM experienced a significant 93% reduction in change compared to the control group. This reduction was consistent with a tau biomarker (p-tau 181 ) in the blood, indicating a potential impact on disease pathology.
Neurofilaments and tau proteins play crucial roles in the structure and function of the brain. In Alzheimer’s disease, tau protein aggregates into toxic fibrils that damage neurons. The amount of neurofilament protein in the bloodstream correlates with tau pathology, disease severity, cognitive decline, and brain atrophy. HMTM, a tau aggregation inhibitor, aims to reduce tau pathology in Alzheimer’s disease.
Henrik Zetterberg, Professor of Neurochemistry at UCL’s Queen Square Institute of Neurology, emphasized the importance of NfL as an Alzheimer’s biomarker for diagnosis and treatment measurement. He stated, “Clinical practice has waited for decades for meaningful advances to address the unmet treatment needs of people with Alzheimer’s. These new results support the importance of NfL as an AD biomarker for both diagnosis and measurement of treatment effect.”
Claude Wischik, Executive Chairman of TauRx, highlighted the significance of the study’s findings, stating, “The NfL results demonstrate that a drug targeting tau pathology reduces the neurodegeneration underlying clinical decline in Alzheimer’s. It brings us one step closer to introducing an effective new treatment option for people with Alzheimer’s. Because HMTM is taken in tablet form and has a good safety profile, it would be easily accessible to people in need of disease-modifying treatment.”
TauRx plans to submit the HMTM results from the LUCIDITY study, along with previous studies, for approval in the US, UK, and other territories.
The LUCIDITY study was a 12-month, double-blind, controlled Phase 3 trial, followed by a 12-month period in which all participants received HMTM at a dose of 16 mg/day. The study compared the 16 mg/day HMTM dose with a control group receiving methylthioninium chloride (MTC) at a dose of 4 mg twice a week for the first 12 months. NfL was the main blood biomarker endpoint in the study, and TauRx is preparing publications to share both the NfL data and the full 24-month data.
Alzheimer’s disease is a leading cause of disability and death worldwide, posing a significant public health issue. TauRx’s focus on developing therapies for neurodegenerative diseases like Alzheimer’s aims to address this unmet need. The positive data from the LUCIDITY study brings them one step closer to seeking regulatory approval and bringing HMTM to the market for patients.
With further research and development, TauRx hopes to advance clinical development in other related neurodegenerative diseases.
About TauRx Pharmaceuticals Ltd
Founded in Singapore in 2002, TauRx has become a leading research company in the field of tau-based research in Alzheimer’s disease. With main research facilities and operations based in Aberdeen, UK, the company has dedicated two decades to developing therapies and diagnostics for Alzheimer’s and other neurodegenerative diseases caused by protein aggregation pathology.
The original article can be found on Business Wire.]
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