TauRx Submits UK Marketing Authorisation Application for HMTM as a Treatment for Alzheimer’s Disease
July 01 2024 - 3:13AM
Business Wire
TauRx Pharmaceuticals Ltd, a global leader in tau-based research
in Alzheimer’s disease (AD), has announced the submission of a UK
Marketing Authorisation Application (MAA) for hydromethylthionine
mesylate (HMTM) for treatment of mild cognitive impairment (MCI-AD)
and mild to moderate stages of dementia due to Alzheimer’s
disease.
HMTM has been designated by the UK’s Medicines and Healthcare
products Regulatory Agency (MHRA) for the Innovative Licensing and
Access Pathway (ILAP). If successful, the UK could be the first
country in which an accessible, safe, oral treatment, which targets
the hallmark tau pathology of the disease, becomes available to
patients.
The MAA is based on the totality of evidence available from the
recently released 24-month Phase 3 LUCIDITY data and two earlier
Phase 3 trials in mild to moderate AD. These studies have been
consistent in showing benefit on measures of decline in cognition,
ability to perform normal activities of daily living, and reduction
in the rate of brain shrinkage.
Tau aggregation is strongly correlated with the rate and
severity of cognitive decline, brain atrophy, and the damage to
neurons responsible for the characteristic neurodegeneration of the
disease. HMTM acts by selectively inhibiting the aggregation of
tau-protein in brain nerve cells. It also has a second mode of
action which results in enhancement of brain functioning.
Commenting on the submission, Professor Claude Wischik,
Executive Chairman of TauRx, said: “This is a significant milestone
for TauRx and is an important step in potentially bringing a new
type of treatment and a new hope to patients and families who carry
the burden of this terrible disease.”
NOTES
ABOUT HMTM
Hydromethylthionine mesylate (HMTM) has been developed as a
potential oral treatment for AD targeting tau aggregation. It also
has a secondary tau-independent mode of action which increases
acetylcholine levels in the hippocampus. The global Phase 3
clinical trial LUCIDITY has recently completed and the data were
presented at the AD/PD™ 2024 Alzheimer's & Parkinson's Diseases
Conference in Lisbon, Portugal, on 7 March. With over 3,000
subjects studied, HMTM has a strong safety profile and could be
delivered with minimal patient and physician burden.
Neurofilament Light Chain (NfL) is an established biomarker for
neurodegeneration. LUCIDITY showed a significant reduction in the
change of NfL, in the randomised double-blind portion of the study
at 12 months. Clinical measures of cognition showed improvement
over baseline levels that was sustained over 18 months in MCI, as
diagnosed in the LUCIDITY trial. Patients who were in the control
group were unable to catch up in terms of cognitive function
despite transitioning to 16mg per day HMTM (target dose) in the
open-label phase after 12 months. This emphasises the importance of
early intervention with effective therapies in AD.
ABOUT TAURx PHARMACEUTICALS LTD
TauRx was founded in 2002 in Singapore, with primary research
facilities and operations based in Aberdeen, UK. In collaboration
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
pathological aggregation of tau and other proteins.
AD is a leading cause of disability and death throughout the
world and is one of the most important global public health issues.
TauRx will contribute to addressing this urgent unmet need with
data from the totality of evidence available from LUCIDITY and the
earlier AD trials in pursuit of regulatory approvals starting in
UK. TauRx’s hope is to make HMTM available for people living with
Alzheimer’s as soon as possible. Future research is planned for
other related neurodegenerative diseases. https://taurx.com/
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