TauRx Pharmaceuticals Ltd., a global leader in tau-based research in Alzheimer’s disease (AD), today announced results from a pre-specified analysis of the Phase 3 LUCIDITY study. The study measured the effects of HMTM on neurofilament light chain (NfL), an established biomarker of neurodegeneration in the brain. Blood levels of NfL showed a statistically significant 93% reduction in change over 12 months in participants receiving HMTM at a dose of 16 mg/day compared to controls, which was clearly consistent with a tau biomarker (p-tau 181 ) in the blood correlated.
Neurofilaments and tau proteins are essential to the neuronal structure and function of the brain. In Alzheimer’s, the tau protein aggregates into toxic fibrils that damage neurons. The extent of this damage can be measured by the amount of neurofilament protein leaking into the bloodstream. Blood NfL levels are known to correlate with tau pathology, disease severity and hence cognitive decline and brain atrophy in Alzheimer’s. The tau aggregation inhibitor HMTM was developed to reduce tau pathology in Alzheimer’s disease. Changes in NfL concentration by HMTM suggest a direct impact on disease pathology.
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“NfL is a well-studied biomarker with broad applicability in various neurological disorders, including Alzheimer’s,” said Henrik Zetterberg, Professor of Neurochemistry at UCL’s Queen Square Institute of Neurology. “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.”
“The NfL results demonstrate that a drug targeting tau pathology reduces the neurodegeneration underlying clinical decline in Alzheimer’s,” said Claude Wischik, Executive Chairman of TauRx. “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 intends to submit the HMTM results from LUCIDITY and previous studies for approval in the US, UK and other territories.
For more information, see: https://taurx.com/ or https://aaic.alz.org/program/scientific-sessions.asp.
THE LUCIDITY STUDY
LUCIDITY is a 12-month, double-blind, controlled, Phase 3 clinical trial followed by a 12-month period in which all participants received HMTM at a dose of 16 mg/day. The study examined the change in various clinical and biomarker outcomes. The HMTM dose of 16 mg/day was compared with methylthioninium chloride (MTC), which was administered as a control at a dose of 4 mg twice a week for the first 12 months. NfL was the main blood biomarker endpoint in this study. The LUCIDITY study is now complete and TauRx is preparing publications that will publish both the NfL data and the full 24-month data.
TAU PATHOLOGY IN ALZHEIMER
Age-related factors lead to misfolding and aggregation of tau proteins and subsequent formation of tau tangles in Alzheimer’s disease. Tau aggregation begins several years before dementia symptoms appear. The pathology of tau aggregation correlates with the clinical deterioration (loss of memory and ability to take care of oneself) commonly seen in people with Alzheimer’s, and thus represents an important target for treatment. HMTM causes inhibition the pathological aggregation of the tau protein.
ABOUT TAURX PHARMACEUTICALS LTD
Founded in Singapore in 2002, TauRx has its main research facilities and operations based in Aberdeen, UK. The company has spent two decades developing therapies and diagnostics for Alzheimer’s and other neurodegenerative diseases that result from protein aggregation pathology.
Alzheimer’s disease is a leading cause of disability and death worldwide and one of the most important public health issues to be addressed worldwide. TauRx aims to help fill this unmet need with LUCIDITY’s data and seek regulatory approval. This is in line with TauRx’s overall plans to bring HMTM to patients and to advance clinical development in other related neurodegenerative diseases. https://www.taurx.com
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