Country for PR: United Kingdom
Contributor: PR Newswire Europe
Thursday, December 01 2022 - 09:13
LUCIDITY phase 3 topline data presented at CTAD for HMTM – the only oral anti-Tau therapy in late-stage development
ABERDEEN, Scotland and SINGAPORE, Nov. 30, 2022 /PRNewswire-AsiaNet/ --

- 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 18 months

ABERDEEN, Scotland and SINGAPORE, Nov. 30, 2022 /PRNewswire/ -- 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 treatments.

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 Alzheimer's disease."

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 


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 


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. 


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.

Source: TauRx Pharmaceuticals Ltd