NeuroSearch presents supportive data on the novel therapy HuntexilTM at the World Congress on Huntington's disease
15-09-09 kl. 15/9 2009 14:38 | NeuroSearch 3,50 (-0,28%)
Copenhagen, 15th September 2009 - NeuroSearch (NEUR) reported today that its
lead specialist product HuntexilTM (pridopidine) is the subject of several key
poster presentations at this year's World Congress on Huntington's disease
(WCHD) in Vancouver. Planned for market launch in 2011, HuntexilTM is in late
stage clinical development as a novel therapeutic for the treatment of
Huntington's disease.
NeuroSearch's presence at the HD congress is substantial and the focus is to
share the most recent update and present supportive data on the company's two
ongoing, large clinical development studies for HuntexilTM: MermaiHD in Europe
and HART in North America[i]. Both studies are designed to investigate the
potential of HuntexilTM as a symptomatic treatment of the voluntary movement
ability in patients with HD. The studies are randomised, double-blinded and
placebo-controlled evaluating the efficacy, safety and tolerability of
different HuntexilTM dosing regimens. Results from MermaiHD are expected in the
beginning of 2010, whilst HART results are anticipated later in 2010.
The information on the key clinical studies for Huntexil™ in HD is supported by
two other poster presentations:
- "Pharmacology of the dopaminergic stabilizer pridopidine" reports findings
from a number of pharmacological studies suggesting that pridopidine stabilizes
psychomotor activity and may therefore offer clinical relief of psychomotor
symptoms arising from dopaminergic dysfunction in conditions such as a HD[ii].
- In "Validation of the modified motor score (mMS): a modified version of the
Unified Huntington's Disease Rating Scale (UHDRS) motor score"[iii] the primary
endpoint used in the MermaiHD and HART studies was presented. The mMS measures
the patients' ability to perform voluntary motor tasks.
Furthermore, the design of Europe's first large scale comprehensive study
measuring the socioeconomic burden of Huntington's disease (Euro-HDB) was
revealed[iv]. The primary objective of the Euro-HDB study is to assess the cost
of HD across six European countries: France, Germany, Italy, Spain, Sweden and
the UK. The study aims to recruit 1,000 patients, to collect information on
clinical characteristics, health-related quality of life (HR-QoL) and
healthcare resource utilisation. The main aim of the study is to demonstrate
the true cost of the illness and to identify any relationships between clinical
status, patient management and patient outcomes.
Dieter H. Meier, Executive Vice President and Chief Medical Officer of
NeuroSearch commented:
"NeuroSearch's substantial presence at this year's WCHD has been very well
received and reconfirms the company's ongoing commitment to delivering both
patients and the professional community a clinically robust novel therapy for
Huntington's disease."
NeuroSearch is dedicated to developing new and effective therapies for areas of
significantly unmet medical need, and develops Huntexil™ to address the limited
treatment options currently available for Huntington's patients and their
treating physicians.
Links to the presentations can be found under "Event calendar" in the IR
section of NeuroSearch's homepage www.neurosearch.com.
Contact persons:
Flemming Pedersen, CEO, telephone + 45 2148 0118
Hanne Leth Hillman, Vice President, Director of Investor & Capital Market
Relations, telephone: +45 4017 5103
Pridopidine (HuntexilTM) - A dopaminergic stabiliser
Pridopidine belongs to a novel class of active agents called dopaminergic
stabilisers, which have the unique ability to both strengthen and inhibit
dopamine-regulated functions in the brain, depending on the base level of
dopamine activity. Dopamine is an important neurotransmitter in the brain, and
the dopaminergic system plays a central role in the control of motor and mental
functions. In preclinical studies dopaminergic stabilisers have demonstrated
the ability to stabilise motor, cognitive and psychiatric dysfunction, and they
do this without compromising normal brain functions.
NeuroSearch is evaluating pridopidine in a pivotal programme for the treatment
of Huntington's disease, comprising of a European Phase III study, MermaiHD,
and a North American Phase IIb confirmatory study, HART. Pridopidine has
previously been evaluated in a Phase II Proof of Concept study in Huntington's
disease with positive results showing a statistically significant improvement
in patients' motor function (gait and parkinsonism) as well as improvements in
their attention and psychiatric symptoms. Further, the agent has been studied
in clinical Phase I studies in Huntington's disease, Parkinson's disease and
schizophrenia with favourable and consistent results.
Pridopidine was discovered by NeuroSearch, which holds the global rights to the
compound. Both the European (EMEA) and the US (FDA) Health Authorities have
granted pridopidine orphan drug designation for the treatment of Huntington's
disease.
Huntington's disease
Huntington's disease is a fatal, 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 with Huntington's
disease experience a wide variety of symptoms, including severe motor
disturbances (both lack of voluntary movements and involuntary movements),
cognitive impairment and psychiatric disorders. Symptoms onset is typically
around 35 and 45 years of age and patients hereafter have a life expectancy of
10 to 15 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. In other parts of the world the prevalence of Huntington's disease is
lower, and the total number of patients affected with the disease 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 afflicted by Huntington's disease will require full-time care.
There is currently no cure or effective treatment for Huntington's disease 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. 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 (Phase III ready), ABT-894 for ADHD (Phase II) in partnership with
Abbott, ACR343 for schizophrenia (Phase II ready), 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 (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.
References
i Tedroff J et al. Pridopidine (ACR16) in Huntington's disease: an update on
the MermaiHD and HART studies. Poster presented at World Congress on
Huntingdon's Disease, Vancouver, Canada, 12-15 September 2009.
ii Waters S et al. Pharmacology of the dopaminergic stabilizer pridopidine
(ACR16). Poster presented at World Congress on Huntingdon's Disease, Vancouver,
Canada, 12-15 September 2009.
iii Waters S et al. Validation of the modified motor score (mMS): a modified
version of the Unified Huntingdon's Disease Rating Scale (UHDRS) motor score.
Poster presented at World Congress on Huntingdon's Disease, Vancouver, Canada,
12-15 September 2009.
iv Toumi M et al. Euro-HDB - the first large European comprehensive study on
the socioeconomic burden of Huntington's disease. Poster presented at World
Congress on Huntingdon's Disease, Vancouver, Canada, 12-15 September 2009.
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