Country for PR: United Kingdom
Contributor: PR Newswire Europe
Wednesday, June 01 2022 - 18:00
Tau-targeting Alzheimer's treatment, HMTM, moving toward regulatory submission based on initial data from TauRx's LUCIDITY trial
SINGAPORE, June 1, 2022 /PRNewswire-AsiaNet/ --

- LUCIDITY data suggest that participants receiving hydromethylthionine 
mesylate (HMTM) decline at a rate substantially less than is typical in 
Alzheimer's based on published research
- Safety profile is favourable and consistent with previous HMTM studies
- TauRx will now pursue regulatory submission and coverage for HMTM

TauRx Pharmaceuticals Ltd, the global leader in tau-based research in 
Alzheimer's, today announced unblinding of initial data from completion of the 
randomised portion of their pivotal Phase 3 clinical trial, LUCIDITY 

TauRx's lead investigative oral drug, HMTM, has been tested in 598 people with 
Alzheimer's. Following our 12 month blinded phase of the study, participants 
have moved forward to an additional one year open label phase.

Professor Claude Wischik, Executive Chairman and Co-Founder of TauRx, 
commented: "The output indicates that participants receiving HMTM decline at a 
rate substantially less than is typical in Alzheimer's based on published 
research. This was seen for both cognitive and functional endpoints across a 
broad range of severity from mild cognitive impairment (MCI) to moderate 
Alzheimer's. Importantly, the safety profile is favourable and consistent with 
previous studies.

"Our data analysis is ongoing and will be reported at a later date. We look 
forward to providing an update on our progress on 9th June 2022 at the 35th 
Global Conference of Alzheimer's Disease International. 

"Our expert advisors including EVERSANA are confident in our moving toward 
regulatory submission and gaining coverage for HMTM.

"Today with limited treatments for Alzheimer's, the standard of care does not 
impact the underlying causes of symptom progression. HMTM aims to significantly 
slow disease progression, providing longer term benefits compared to 
medications brought to market almost twenty years ago."

Prior to the release of the LUCIDITY interim data, the UK Medicines & 
Healthcare products Regulatory Agency (MHRA) granted the company an Innovation 
Passport on 18th May 2022. The Innovation Passport is the first stage of the 
Innovative Licensing and Access Pathway (ILAP), which is intended to accelerate 
development and approval times, facilitating access to new products and 

Professor Wischik explains, "The ILAP designation represents a clear signal of 
regulatory support for a prospective treatment breakthrough in Alzheimer's, 
which remains one of the world's greatest unmet medical needs. Dementia is a 
leading cause of death around the world, and the Innovation Passport, as the 
first stage of the ILAP scheme, enables access to the collaborative approach of 
regulators and associated health technology assessment bodies to both drug 
licensing and access throughout the UK.

"We recognise and publicly thank the incredible commitment from participants 
and partners involved in LUCIDITY. Our scientific focus on the role of tau 
pathology in neurodegenerative disease with support from our shareholders and 
team has enabled us to reach this important milestone."

With the vision to change the diagnostic and dementia care landscape, the joint 
venture between TauRx and Genting Berhad, GT Diagnostics, continues to move 
forward with developing new diagnostic tau biomarker and psychometric tools. 
These tools will aid in earlier and more accurate identification of people with 
Alzheimer's and are designed to assist in management through the progression of 

With an estimated 50 million people worldwide with Alzheimer's, their families, 
healthcare professionals and society, TauRx share their aim in finding a safe 
and effective management.

LUCIDITY is the only late-stage clinical trial specifically targeting the tau 
pathology of Alzheimer's. Aggregation of abnormal tau protein is one of the 
hallmark pathologies. Tau aggregation and the subsequent formation of tau 
tangles disrupt neuronal function, a process that begins many years before 
symptoms of dementia are seen. Tau pathology correlates strongly with 
Alzheimer's severity and the clinical decline (loss of memory and ability to 
care for one's self) commonly seen in people with Alzheimer's.

The LUCIDITY trial is designed to confirm the efficacy of HMTM* and support 
regulatory submission as the first disease modifying Alzheimer's treatment for 
Mild Cognitive Impairment and Mild-to-Moderate stages. The trial background and 
design are described in an upcoming paper in the Journal of Prevention of 
Alzheimer's Disease (JPAD).

*Previously also abbreviated to LMTM and LMTX. 

In 2002 TauRx Therapeutics Ltd. was established in Singapore, in our continuing 
partnership with the University of Aberdeen. The company has dedicated the past 
two decades to developing treatments and diagnostics for Alzheimer's and other 
neurodegenerative diseases due to protein aggregation pathology. TauRx's 
primary research facilities and operations are based in Aberdeen, UK.

Genting TauRx Diagnostic Centre Sdn Bhd, a company established in Malaysia, and 
its wholly owned subsidiary GT Diagnostics (UK) Limited (collectively, "GT 
Diagnostics") was founded as a collaboration between Genting Berhad and TauRx 
Pharmaceuticals Ltd Group and is currently developing new tau biomarker and 
psychometric tools for people with Alzheimer's, caregivers and clinicians for 
early detection of Alzheimer's. GT Diagnostics currently develops readily 
deployable e-platform tools for home use as well-being apps, alongside 
professional tools for expert use to aid diagnosis and monitoring of dementias.

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Source:  TauRx Pharmaceuticals Ltd