PR96281

SINGAPORE, June 1, 2022 /PRNewswire=KYODO JBN/ --

- 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

(NCT03446001).

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

indications.

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

symptoms.

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.

ABOUT LUCIDITY

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.

https://www.luciditytrial.com/

ABOUT TAURx PHARMACEUTICALS LTD

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.

https://www.taurx.com/

ABOUT GT DIAGNOSTICS

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.

https://www.gtdiag.com/

Newsroom at: https://news.cision.com/taurx

Source:  TauRx Pharmaceuticals Ltd