Tau-targeting Alzheimer's treatment, HMTM, moving toward regulatory submission based on initial data from TauRx's LUCIDITY trial
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.
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.
Newsroom at: https://news.cision.com/taurx
Source: TauRx Pharmaceuticals Ltd
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