Aberdeen, Scotland and Singapore (ots/PRNewswire) - - Tau aggregation
inhibitor, HMTM, is an oral drug with a strong safety profile, having
no risk of amyloid related imaging abnormalities
- Topline results for the Phase 3 study, LUCIDITY, were shared at the
Clinical Trials in Alzheimer's Disease (CTAD) conference on
Wednesday, 30th November 2022, in San Francisco
- For people with early Alzheimer's (MCI), HMTM improvement in
cognition over pre-treatment baseline now shown to be sustained over
TauRx Pharmaceuticals Ltd is a global leader in Tau-based research in
Alzheimer's disease (AD), being the only company running late-stage
clinical trials for a potential therapy designed to target the Tau
pathology of Alzheimer's. Pathological aggregation of Tau correlates
with clinical disease severity and brain atrophy. As a hallmark of
the disease, it is recognised as a key target for disease modifying
This approach by TauRx contrasts to many in the field, where the
focus has largely been on the role of beta-amyloid. Experts in the
field are increasingly looking at alternative therapeutic approaches
to find a breakthrough treatment that offers clinically meaningful
benefit, ease of administration and low burden of care associated
with a reassuring safety profile.
Supporting a path to regulatory submissions, the most recent data
from LUCIDITY shows sustained improvement in cognition over 18 months
over pre-treatment levels in those participants with MCI due to AD,
building on previous data shared in October 2022. This treatment
effect was seen only at the 16 mg/day dose of HMTM. Sustained
cognitive improvement over baseline has not been seen with any other
late-stage treatment for Alzheimer's currently being studied. Coupled
with the strong safety profile, convenient oral administration, and
lack of need for more than routine clinical monitoring, this
positions HMTM as a game-changing prospect for the future treatment
of this global unmet need.
On hearing the data and explanations for the path forward from TauRx,
Dr George Grossberg, Professor, Director Division of Geriatric
Psychiatry Department of Psychiatry & Behavioural Neuroscience, St
Louis University School of Medicine, commented, "It is encouraging to
see data on a potential disease modifying therapy focusing on the
role of Tau in Alzheimer's disease. Being an oral agent with a good
safety profile is another advance in the disease-modifying arena for
TauRx will announce further data on completion of the 24-month study
in mid-2023, with additional blood-based biomarker data commissioned
to be available early next year. Meanwhile, TauRx is preparing for
regulatory submissions primarily in the UK, US, and Canada, with
other key territories on their target list, including China, to
follow alongside additional studies.
The recent announcement of additional investment of USD119 million
through a warrants exercise triggered by the study results allows the
company to move forward with regulatory submissions and preparation
for market availability.
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.
Additional data analysis is ongoing in relation to the 1-year open
label phase of the trial, secondary endpoints including MRI
volumetric brain scans, and exploratory endpoints. A summary of the
LUCIDITY study protocol has recently been published in The Journal of
Prevention of Alzheimer's Disease
ABOUT TAURx PHARMACEUTICALS LTD
The TauRx group of companies was established in 2002 in Singapore,
continuing a partnership with the University of Aberdeen, with
primary research facilities and operation based in Aberdeen, UK. 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.
Alzheimer's dementia is a leading cause of death throughout the world
and one of the most important public health issues to be addressed
globally. TauRx will contribute to addressing this unmet need with
data from LUCIDITY and pursuit of regulatory approvals in line with
its overall plans to commercialise HMTM and pursue clinical trials in
other related neurodegenerative diseases.
TAU PATHOLOGY IN ALZHEIMER'S
Through dedicated research programs, it is understood that certain
age-related factors lead to misfolding and aggregation of tau
proteins, and the subsequent formation of tau tangles in Alzheimer's.
These tangles disrupt and damage neuronal function, a process that
begins many years before symptoms of dementia are seen. Tau pathology
has been proven to correlate with the clinical decline (loss of
memory and ability to care for oneself) commonly seen in people with
Alzheimer's, establishing it as an important target for treatment.
HMTM is a tau aggregation inhibitor, which effectively crosses the
blood brain barrier to target the source of this damaging process.
Digital press kit: http://www.ots.at/pressemappe/PR162589/aom
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