COPENHAGEN and BALLERUP, Denmark, March 8, 2010 (GLOBE NEWSWIRE) --
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.
