NeuroSearch presents additional data from the MermaiHD study with Huntexil® at the 5th Annual CHDI Conference on Huntington's disease


Copenhagen, 11 February 2010 - Today, at the 5th Annual CHDI Conference on
Huntington's disease, held 8 to 11 February in Palm Springs, California,
NeuroSearch (NEUR.CO) presented the results from the MermaiHD study, a Phase
III study with Huntexil® (pridopidine) for the treatment of Huntington's
disease. Top-line results from the study were announced on 3 February 2010
(Announcement no. 01-10), 

Presenting as the featured speaker at the conference, Dr. Joakim Tedroff, Head
of Clinical Science at NeuroSearch on Wednesday 10 February, 4pm to 5pm PDT
(Thursday, 1am to 2am CET) presented the study results, including the
following: 

•	Efficacy - Results from the MermaiHD study demonstrate that six months' (26
weeks) treatment with Huntexil® (45 mg BID), in Huntington's patients
significantly improves both voluntary movement control, as measured on the
primary endpoint, the mMS, and also a broader range of voluntary and
involuntary motor symptoms, including dystonia and eye movements. Measured in
both the ITT (Intention to treat) and the PP (per protocol, 82% of patients))
populations, the improvements seen were highly statistically significant, and
thereby the results in the PP population fully confirm the ITT analysis : 

Motor scale; Significance level for the PP population; Significance level for
the ITT population; 
Modified Motor Score, mMS;	p <0.005; p <0.02;
Total Motor Score, TMS; p <0.005; p <0.001;
Eye Movements	p <0.02	p <0.002
Dystonia	p <0.01	p <0.001


•	Cognitive testing - On one of the cognitive measures, the Trail Making test,
included in the MermaiHD study as a secondary endpoint, six months treatment
with Huntexil® 45mg BID showed a significant improvement (ITT; p <0.05). 

•	Safety and compliance - Over the six months of treatment in the study, less
than two thirds of all patients reported adverse events. The most frequently
observed adverse events were falls, dizziness, Huntington's chorea, diarrhoea,
nausea, nasopharyngitis, depression, fatigue and insomnia, occurring at a
frequency between 3% and 9% and equally distributed between the active
treatment groups and placebo. In total, the study had a high completion rate,
and with less than 4% of patients withdrawing from the study due to adverse
events: 



Placebo; Huntexil® 45 mg QD; Huntexil® 45 mg BID;
Randomised pts (ITT); 144; 148; 145;
Completers; 129 (90%); 143 (97%); 131 (90%);
Withdrawals due to AE; 8 (6%); 2 (1%); 7 (5%);
Any adverse event;	64%; 61%; 68%;

The study showed no worsening of any disease signs and symptoms, including
Huntington's chorea, on which measure both the ITT and the PP analyses showed
no difference compared to placebo. 

•	Patient demographics - Patient randomization in the MermaiHD study was
successful with patients in the three study arms (Huntexil® 45 mg QD; Huntexil®
45 mg BID; and placebo) expressing similar demographic characteristics. At
baseline, the mean age across the study was 50.6 years, time since diagnose 4.8
years and the mean CAG repeats was 44.7 (between 36 and 63). Out of the total
number of randomized patients, 190 (43.5%) were on antipsychotic medication,
and 247 (56.5%) were not. 


Insight into the unique pharmacology of Huntexil® 
Huntexil® (pridopidine) exerts its pharmacological effect via induction of a
unique functional modulation of dopamine D2 receptors primarily in the
striatum. This functional feature of the compound has recently been published
in the European Journal of Pharmacology (2010, issue 628, pp 19-26 by T.
Dyhring et al.; The dopaminergic stabilizers pridopidine (ACR16) and
(−)-OSU6162 display dopamine D2 receptor antagonism and fast receptor
dissociation properties. 

Further, in vivo studies have shown that Huntexil® strengthens the glutamate
function in the cortex, an effect most likely to be mediated by the release of
dopamine and consequently D1 activation. 

Huntington's disease is associated with dopaminergic dysfunction and disruptive
corticostriatal circuitry, and the combined effect of Huntexil® on both the
dopaminergic and glutamatergic systems is believed to account for the observed
partial normalization of motor dysfunctions in Huntington patients. 


Conclusions from the MermaiHD study
In the MermaiHD study, six months' treatment with Huntexil® has shown to
significantly improve both voluntary and involuntary motor functions,
translating into a ½ to 1½ years of set-back in the natural progression of
these disease symptoms. Importantly, this improvement is seen without any
''therapeutic" disadvantages in terms of worsening of other disease signs or
symptoms and with good safety. 

Following the results from the MermaiHD study, NeuroSearch has undertaken
further in-depth analysis of the results and initiated dialogue with regulatory
authorities to discuss the study outcome and plans for market registration of
Huntexil® as a novel treatment for Huntington's disease. 


Flemming Pedersen
CEO
Contact persons:
Flemming Pedersen, CEO, telephone: +45 4460 8214 or +45 2148 0118
Hanne Leth Hillman, Vice President, Director of Investor & Capital Market
Relations, telephone: +45 4017 5103 



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® 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® doses
(45 mg QD or 45 mg BID) or placebo during a six month double-blinded phase.
Hereafter, they have been offered to continue into a six month open-label
extension phase, in which they receive treatment with Huntexil® 45 mg BID only.
The last patient completed the double-blinded phase in November 2009, and of
the total number of patients having completed six months 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) and measures a broader
range of motor symptoms, including voluntary motor function (mMS and eye
movements) and also involuntary movements such as dystonia and chorea. Further
study endpoints include the TMS, cognitive function, behaviour and symptoms of
depression and anxiety. 

About Huntington's disease
Huntington's disease (HD) 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. Patients
suffering from HD 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 have
a life expectancy of 10 to 20 years. 
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 HD prevalence is lower, and the
total number of patients suffering from HD outside North America and Europe is
estimated at 30,000 to 35,000. The rate of diagnose also varies among
geographic regions. 
After symptoms onset the disease progresses without remission and 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® (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.

Attachments

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