TauRx Pharmaceuticals Ltd, a leader in tau-based research for Alzheimer’s disease (AD), has submitted a UK Marketing Authorisation Application (MAA) for hydromethylthionine mesylate (HMTM) to treat mild cognitive impairment (MCI-AD) and mild to moderate dementia stages caused by Alzheimer’s disease.
“This milestone is crucial for TauRx and marks a significant step towards potentially offering a new treatment option and hope to patients and families affected by this devastating disease.”
HMTM has been designated by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the Innovative Licensing and Access Pathway (ILAP). Successful approval would make the UK the first country to provide accessible, safe, oral treatment targeting tau pathology, a hallmark of Alzheimer’s disease.
The MAA is supported by comprehensive evidence from the recently released 24-month Phase 3 LUCIDITY data and earlier Phase 3 trials in mild to moderate AD. These studies consistently show benefits in cognition decline, daily activity performance, and reduction in brain shrinkage.
Tau aggregation correlates strongly with cognitive decline severity, brain atrophy, and neuron damage in Alzheimer’s disease. HMTM inhibits tau-protein aggregation selectively in brain nerve cells and enhances brain function through a secondary mechanism.
Professor Claude Wischik, Executive Chairman of TauRx, emphasized, “This submission is a pivotal moment for TauRx, aiming to introduce a new treatment option and renewed hope for patients and their families grappling with this devastating disease.”
Notes:
About HMTM:
Hydromethylthionine mesylate (HMTM) is developed as an oral treatment targeting tau aggregation in Alzheimer’s disease, with an additional mode of action increasing acetylcholine levels in the hippocampus. The global Phase 3 LUCIDITY trial recently concluded, showcasing strong safety with over 3,000 subjects and minimal burden on patients and physicians.
Neurofilament Light Chain (NfL) serves as a biomarker for neurodegeneration. LUCIDITY demonstrated significant reduction in NfL change during the double-blind study’s 12-month period. Cognitive improvements persisted over 18 months in MCI cases diagnosed during the trial.
About TauRx Pharmaceuticals Ltd:
Founded in Singapore in 2002, TauRx operates primary research facilities in Aberdeen, UK, focusing on Alzheimer’s and other neurodegenerative diseases linked to tau and protein aggregation. Alzheimer’s disease remains a critical global public health challenge, driving TauRx’s commitment to advancing regulatory approvals, starting with the UK, to make HMTM accessible for Alzheimer’s patients as swiftly as possible.
