PR99055

- 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 =KYODO JBN / -- 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 [

https://taurx.com/news-insights/taurx-announces-results-from-phase-3-alzheimers-disease-study-lucidity-assuring-path-for-regulatory-submissions

]. 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 [

https://taurx.com/news-insights/taurx-announces-additional-investment-of-usd119-million-following-announcement-of-phase-3-lucidity-topline-results

] through a warrants exercise triggered by the study results allows the company

to move forward with regulatory submissions and preparation for market

availability.

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.

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

[http://dx.doi.org/10.14283/jpad.2022.63].

https://www.luciditytrial.com

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.

https://www.taurx.com

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.

Source: TauRx Pharmaceuticals Ltd