NeuroSearch (NEUR) today announced that further analysis of the
data from the MermaiHD study with Huntexil(R) (pridopidine) for the
treatment of Huntington's disease supports potential disease
modifying properties of the drug.
Top line results from the MermaiHD study, a six months European
Phase III study in 437 patients with Huntington's disease, was
announced and presented in the beginning of February, showing that
treatment with Huntexil(R) significantly improves patients' motor
function with effects seen on both the voluntary and involuntary
motor symptoms associated with the disease.
Additional analysis of results from the study shows that
Huntexil(R) not only has symptomatic effect, but also appears to
slow the underlying disease progression depending on the patients'
disease-genotype. In line with recently published academic findings
(Aziz et al., 2009, Ravina et al., 2008), data from the placebo
treated patient group in the MermaiHD study confirm a strong
correlation between the length of the Huntington's disease gene and
the rate of symptoms progression. The more CAG repeats there are in
the gene, the faster is the progression of clinical symptoms. In
the Huntexil(R) treated patients the CAG dependent rate of motor
symptoms progression as observed in the placebo group, was not
apparent, lending support to the drug's ability to potentially
modify the underlying disease progression.
Following these important additional findings, NeuroSearch has
filed a patent application covering the ability of Huntexil(R) to
slow down the progression of disease in symptomatic Huntington
patients as well as prevent the occurrence of symptoms in
pre-manifest subjects. The patent application describes the
discovery that Huntexil(R), in addition to its ability to reduce
symptoms as previously shown, demonstrates disease modifying
properties. The patent application also covers other proprietary
compounds in NeuroSearch's portfolio of dopaminergic
stabilizers.
Professor Justo Garcia de Yebenez, Hospital Ramon y Cajal,
Madrid, Spain and primary investigator in the MermaiHD study,
commented;
"The new findings from the MermaiHD study pointing towards a
potential disease modifying impact from treatment with Huntexil(R)
are very important. Apart from offering an improvement of symptoms
associated with the disease, ability to slow the underlying disease
progression would be a tremendous step forward in the treatment of
Huntington patients, potentially starting already at the
pre-symptomatic stage. I am looking forward to working together
with NeuroSearch to further investigate the full potential of
Huntexil(R)."
NeuroSearch continues the dedicated work to further analyse the
data from the MermaiHD study and from other clinical studies once
data are available and with the aim of exploring the properties of
Huntexil(R) both as an effective and safe treatment of some of the
most burdensome symptoms of Huntington's disease and as a potential
means of slowing down the natural disease progression.
Flemming Pedersen
CEO
References
Aziz et al., "Normal and mutant HTT interact to affect clinical
severity and progression in Huntington's disease"; Neurology, 2009;
73; 1280-1285
Ravina et al., "The Relationship Between CAG Repeat Length and
Clinical Progression in Huntington's Disease"; Movement Disorders,
vol. 23, No. 9, 2008, pp. 1223-1227
About the MermaiHD study
The MermaiHD study is a randomised, double-blinded and
placebo-controlled Phase III study conducted at 32 clinical centres
across Europe to examine the effects of Huntexil(R) on a number of
Huntington's disease parameters.
The study has enrolled 437 patients with Huntington's disease
from Austria, Belgium, France, Germany, Italy, Portugal, Spain and
the UK. The patients have been randomly allocated to receive
treatment with one of two Huntexil(R) doses (45 mg. once or twice
daily) or placebo during a 6-month double-blinded phase. Hereafter,
they have been offered to continue into a 6-month open-label
extension phase, in which they receive treatment with 45 mg.
Huntexil(R) twice daily, only. The last patient completed the
double-blinded phase in November 2009, and of the total number of
patients having completed 6 month of randomised treatment, almost
90% have chosen to continue into the open-label extension
phase.
The primary study endpoint is voluntary motor function in
Huntington patients, measured on the modified Motor Score (mMS),
The mMS is defined as the sum score of voluntary motor items from
the Total Motor Score (TMS), The TMS is part of the Unified
Huntington's Disease Rating Scale (UHDRS), encompassing the full
range of motor symptoms associated with the disease, including both
voluntary motor function (mMS and eye movements) and involuntary
movements such as dystonia and chorea. TMS is also included as
endpoint in the study. Other endpoints include cognitive function,
behaviour and symptoms of depression and anxiety.
About Huntington's disease
Huntington's disease is a highly disabling, hereditary
neurodegenerative genetic disorder, which leads to damage of the
nerve cells in certain areas of the brain including the basal
ganglia and the cerebral cortex.
The disease occurs at a rate of about one in every 10,000 in
most western countries with an estimated 70,000 affected patients
in North America and Europe combined. In other parts of the world,
the disease prevalence varies substantially among geographic
regions and is generally lower. The total number of patients
outside North America and Europe is estimated to be in the range of
30,000 to 35,000.
Patients with Huntington's disease experience a wide variety of
symptoms typically grouped into three categories: motor, cognitive
and psychiatric symptoms. The onset of symptoms is typically around
35 and 45 years of age, and patients hereafter deteriorate
gradually with a life expectancy of 10 to 20 years. Eventually
every person with Huntington's disease will require full-time care.
Huntington's disease represents high unmet medical needs, as there
is currently no cure or effective treatment available and only a
limited number of novel drugs in development.
About NeuroSearch - Company profile
NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company
listed on NASDAQ OMX Copenhagen A/S. The core business of the
company covers the development of novel pharmaceutical agents,
based on a broad and well-established drug discovery platform,
focusing on ion channels and central nervous system (CNS)
disorders. A substantial share of the activities is partner
financed through strategic alliances with Janssen Pharmaceutica,
Eli Lilly and Company and GlaxoSmithKline (GSK), and a license
collaboration with Abbott. The drug pipeline comprises eight
clinical (Phase I-III) development programmes: Huntexil(R)
(pridopidine) for Huntington's disease (Phase III), tesofensine for
obesity (ready for Phase III), ABT-894 for ADHD (Phase II) in
partnership with Abbott, ACR343 for schizophrenia (ready for Phase
II), ACR325 to treat dyskinesias in Parkinson's disease (Phase Ib),
ABT-560 for the treatment of cognitive dysfunctions (Phase I) in
collaboration with Abbott, NSD-788 for anxiety/depression (Phase I)
and NSD-721 for social anxiety disorder (Phase I) in partnership
with GSK. In addition, NeuroSearch has a broad portfolio of
preclinical drug candidates and holds equity interests in several
biotech companies.
CONTACT: NeuroSearch A/S
Flemming Pedersen, CEO
+ 45 4460 8214
+ 45 2148 0118
Hanne Leth Hillman, Vice President, Director of Investor
&
Capital Market Relations
+45 4460 8212
Cell: +45 4017 5103