TauRx Submits UK Marketing Application for Alzheimer's Drug HMTM

ABERDEEN, UK I July 01, 2024 I TauRx Pharmaceuticals Ltd, a globally recognized leader in tau-based research for Alzheimer’s disease (AD), has officially submitted a UK Marketing Authorisation Application (MAA) for hydromethylthionine mesylate (HMTM). This drug is intended for the treatment of mild cognitive impairment (MCI-AD) and early to moderate stages of dementia associated with Alzheimer’s disease.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has designated HMTM for the Innovative Licensing and Access Pathway (ILAP). If approved, the UK could become the first country to offer an accessible, safe, oral treatment that specifically targets the tau pathology characteristic of Alzheimer’s disease.

The MAA is supported by comprehensive evidence from the recently concluded 24-month Phase 3 LUCIDITY trial, along with data from two previous Phase 3 trials focusing on mild to moderate AD. These studies uniformly demonstrate the drug's benefits in slowing cognitive decline, enhancing daily living activities, and reducing brain shrinkage rates.

Tau protein aggregation is strongly linked to the severity and speed of cognitive decline, brain atrophy, and neuron damage, which are all hallmarks of Alzheimer’s disease. HMTM works by selectively preventing the aggregation of tau proteins in brain nerve cells. Furthermore, it has a secondary mechanism that enhances overall brain function.

Commenting on the submission, Professor Claude Wischik, Executive Chairman of TauRx, stated, "This is a significant milestone for TauRx and an important step in potentially bringing a new type of treatment and hope to patients and families burdened by this devastating disease."

Hydromethylthionine mesylate (HMTM) has been developed as a promising oral treatment targeting tau aggregation in Alzheimer's disease. Additionally, it has a secondary mode of action that boosts acetylcholine levels in the hippocampus. The global Phase 3 clinical trial LUCIDITY has recently concluded, with findings presented at the 2024 Alzheimer’s & Parkinson’s Diseases Conference in Lisbon, Portugal, on March 7. With over 3,000 subjects involved, HMTM has demonstrated a robust safety profile and can be administered with minimal burden to patients and physicians.

Neurofilament Light Chain (NfL) is a recognized biomarker for neurodegeneration. In the LUCIDITY trial, a significant reduction in NfL levels was observed during the randomized double-blind portion at 12 months. Clinical measures of cognition showed improvement over baseline levels, sustained for 18 months in MCI-diagnosed patients. Those in the control group could not catch up in cognitive function even after transitioning to a 16mg per day HMTM dose during the open-label phase after 12 months. This underscores the importance of early intervention with effective therapies in Alzheimer’s disease.

TauRx Pharmaceuticals Ltd, founded in 2002 in Singapore, operates its primary research facilities in Aberdeen, UK, in collaboration with the University of Aberdeen. Over the past two decades, the company has focused on developing treatments and diagnostics for Alzheimer’s and other neurodegenerative diseases caused by pathological protein aggregation.

Alzheimer’s disease is a leading cause of disability and death worldwide, representing a significant global public health issue. TauRx is committed to addressing this urgent need by seeking regulatory approvals based on the totality of evidence from the LUCIDITY and earlier AD trials, beginning in the UK. The company aims to make HMTM available to those living with Alzheimer’s as soon as possible and plans to extend its research to other related neurodegenerative diseases.