Monday, July 17, 2023
TauRx Therapeutics Ltd., a leading global player in Alzheimer's disease (AD) research focusing on tau pathology, has unveiled the outcomes of the LUCIDITY Phase 3 clinical trial. The study assessed the impact of their drug, Hydromethylthionine Mesylate (HMTM), on neurofilament light chain (NfL), a well-established biomarker for brain neurodegenerative diseases. Subjects receiving 16 mg/day of HMTM experienced a remarkable 93% reduction in NfL blood concentrations over a 12-month period compared to the control group, which was associated with tau in blood as evidenced by the biomarker p-tau 181.
Neurofilament and tau proteins are pivotal for brain neuronal structure and function. In AD, tau aggregates form toxic fibrils, harming neurons. Neurofilament protein levels in the bloodstream indicate the extent of this damage. Elevated NfL concentrations correlate with tau pathology, AD severity, cognitive decline, and brain atrophy. HMTM, a tau protein aggregation inhibitor, aims to mitigate tau-related pathology in AD. The positive impact of HMTM on NfL concentrations directly signifies its effect on disease pathology.
Henrik Zetterberg, a neurochemistry professor at the Queen Square Neurological Institute, University of California, USA, praised the significance of the NfL findings: "NfL is a well-studied biomarker with broad applicability in various neurological diseases, including AD. These results address the unmet needs of AD patients and further validate NfL's importance as an AD biomarker for diagnosis and treatment efficacy assessment."
Claude Wischik, Executive Chairman of TauRx, emphasized the implications of the NfL results: "The findings underscore the potential of drugs targeting tau protein pathology to reduce neurological degeneration, a key aspect of AD's clinical deterioration. This moves us closer to providing an effective new treatment option. With HMTM administered as a lozenge and boasting a robust safety profile, it will be a viable option for those needing disease-modifying treatment."
TauRx intends to submit HMTM trial results from LUCIDITY and early-stage trials for regulatory approval in the US, UK, and other relevant jurisdictions.