TauRx Reports First Phase 3 Results for LMTX®

Aberdeen, Scotland and Singapore (ots/PRNewswire) -

Promising Read-Out for First-Ever Tau Aggregation Inhibitor to
Enter Phase 3 Trials

- LMTX® as monotherapy demonstrates significant reductions in disease
progression in mild and moderate Alzheimer's disease
- Strong results in both cognitive and functional tests supported by
brain scan evidence of slow-down in progression of pathology
- Study misses co-primary endpoints as LMTX® as add-on therapy shows
no beneficial effects
- Initial analysis from second phase 3 study in patients with mild
Alzheimer's disease confirm positive findings

TauRx Therapeutics Ltd today announced Phase 3 clinical trial
results that show treatment with LMTX®, the company's novel tau
aggregation inhibitor, had a marked beneficial effect on key measures
of Alzheimer's disease in patients with mild or moderate forms of the
disease.

(Logo: http://photos.prnewswire.com/prnh/20160727/393315LOGO )

While the TRx-237-015 study in 891 subjects failed to meet its
co-primary endpoints, clinically meaningful and statistically
significant reductions in the rate of disease progression were
observed across three key measures in patients who were treated with
LMTX® as their only Alzheimer's disease medication. These three key
measures comprised a cognitive assessment (ADAS-Cog), a functional
assessment (ADCS-ADL) and an assessment of the level of brain atrophy
(lateral ventricular volume, LVV, as measured by MRI). An abstract of
the results will be presented during an open session at the 2016
Alzheimer's Association International Conference (AAIC) in Toronto,
Canada this afternoon by Dr. Serge Gauthier, CM, MD, FRCPC, Director
of the Alzheimer's Disease Research Unit, McGill University, Canada.

"In a study of this size across a combined mild to moderate
patient population, it is both encouraging to see improvements of
this magnitude in the standard cognitive and functional tests and
reassuring to see the supporting brain scan evidence of a slowing in
disease progression during 15 months of treatment," said Dr.
Gauthier, "As a practising clinician I see Alzheimer's patients,
their families and care-givers every day, and continually share their
desperate need for a truly therapeutic product as today we only have
symptomatic treatments available to us. In a field that has been
plagued by consistent failures of novel drug candidates in late-stage
clinical trials and where there has been no practical therapeutic
advance for over a decade, I am excited about the promise of LMTX® as
a potential new treatment option for these patients."

The same efficacy findings were not seen in study patients who
took LMTX® in combination with other standard Alzheimer's treatments.
Since these patients formed the substantial majority of those
recruited to the trial, the treatment benefits seen in those taking
LMTX® as monotherapy could not be seen when all patients taking LMTX®
were pooled in the primary analysis model. Although this prevented
the study from achieving an overall statistical significance in the
pooled analysis, the primary analysis model showed a highly
significant effect of treatment in the patients taking LMTX® as
monotherapy. This treatment benefit was confirmed in a prespecified
supportive analysis of all of the study's primary and secondary
outcomes. This is the first treatment in which a clinical effect has
been supported by evidence in delay of progression in brain atrophy
shown by MRI scans.

Professor Claude Wischik, Professor of Psychiatric Geratology at
Aberdeen University and co-founder of TauRx said, "The results we
have seen in this study confirm the results we saw in our Phase 2
study, where an earlier version of the drug was also given as
monotherapy. The results we see in those patients not taking
Alzheimer's disease medications show the considerable potential of
LMTX® as a monotherapy for both mild and moderate Alzheimer's
disease. Perhaps more importantly, these results support the
targeting of the tau tangle pathology in Alzheimer's disease as being
a very promising drug development pathway. However, the reason for
the observed loss of efficacy of LMTX® when taken in combination with
currently available treatments for Alzheimer's disease is not as yet
understood."

An initial analysis of data from the second of TauRx's two Phase 3
trials in Alzheimer's disease, study TRx-237-005 undertaken in 800
patients with the mild form of the disease, confirms the findings of
study TRx-237-015 and supports the potential of LMTX® as monotherapy.
The results from this study are expected to be published and
presented later in 2016.

Impact of LMTX® Treatment on Key AD Measures

- The ADAS-cog decline analysis produced highly statistically
significant treatment effects of -6.3 +/-1.4 (p<.0001) and -5.8
+/-1.4 (p<.0001) units after taking 75mg b.i.d or 125mg b.i.d of
LMTX® as monotherapy respectively, while the ADCS-ADL decline
analysis produced a statistically significant treatment effect of
6.5 +/-1.8 (p=.0013) and 6.9 +/-1.9 (p=.0007) following treatment
of 75mg b.i.d or 125mg b.i.d of LMTX® as monotherapy respectively.
- LMTX® taken as monotherapy also slowed down the rate of progression
of brain atrophy as measured by LVV derived from MRI scans. There
was a reduction in the expansion of the LVV by 38%+/-9% (p=.0023)
and 33%+/-9% (p=.0014) for 75mg twice a day and 125mg twice a day,
respectively, compared to the control in these patients. These
reductions in LVV expansion were statistically significant and
confirmed by corresponding increases in the whole brain volumes in
the same patient groups.
- In those study patients taking LMTX® as add-on therapy to current
AD medications, there were no statistically significant differences
in ADAS-cog, ADCS-ADL or LVV measurements between the control, 75mg
b.i.d LMTX® or 125 mg b.i.d. LMTX® treatment groups.

About Study TRx-237-015

Study TRx-237-015, was a randomised double-blind
placebo-controlled study in 891 subjects with mild or moderate
Alzheimer's disease that compared treatment for 15 months with LMTX®
with placebo. The safety profile of LMTX® in the study was
acceptable, with rates of amyloid-related imaging abnormalities
reported similar to placebo arms in recent Phase 3 trials and with
the overall adverse event profile also similar to those typically
seen in Phase 3 studies of novel late-stage Alzheimer's disease
treatments. The most common adverse events occurred in the
gastrointestinal and urinary tracts, and were typically mild in
nature and easily controlled.

Data Presentation Details

Study TRx-237-015 will be presented at an oral session at AAIC on
27 July 2016, 16:15-17:45.

Tau aggregation inhibitors

TauRx's tau aggregation inhibitors (TAIs) have arisen from nearly
30 years of research. TAIs work by undoing the tau tangles that cause
dementia, thereby slowing and even arresting memory loss[1]. The
first-generation TAI, rember®, was a patented, highly-purified
version of methylene blue, a compound previously used to treat a
variety of conditions.

About TauRx Therapeutics Ltd

TauRx Therapeutics Ltd is a member of the TauRx Pharmaceuticals
group which is developing technology spun-out from the University of
Aberdeen, Scotland, and was established in Singapore in 2002 with the
aim of developing new treatments and diagnostics for a range of
neurodegenerative diseases. The company's tau aggregation inhibitor,
LMTX® targets aggregates of abnormal fibres of tau protein that form
inside nerve cells in the brain, giving rise to 'tau tangles'.
TauRx's headquarters are in Singapore and its primary research
facilities are based in Aberdeen. For more information, please visit:
http://www.taurx.com.

References

1. Wischik CM, et al. Tau-aggregation inhibitor therapy for
Alzheimer's disease. Biochem Pharmacol 2014;88:529-39.

Email: taurxpress@hkstrategies.com

Website: http://www.taurx.com

ots Originaltext: TauRx Therapeutics
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