Click
Chat
 
Du kan vedhæfte PDF, JPG, PNG, DOC(X), XLS(X) og TXT-filer. Klik på ikonet, vælg fil og vent til upload er færdig før du indsender eller uploader endnu en fil.
60
Vedhæft Send
DANMARKS STØRSTE INVESTORSITE MED DEBAT, CHAT OG NYHEDER

NeuroSearch announces positive top-line results from Phase III Huntexil® study in Huntington's disease (the MermaiHD study)

03-02-10 kl. 3/2 2010 07:54 | NeuroSearch 3,50 (-0,28%)

- Huntexil® significantly improves motor functions in Huntington patients
- Positive effects observed on both voluntary and involuntary motor symptoms
- Huntexil® was very well tolerated with an adverse event profile similar to
placebo

Copenhagen, 3 February 2010 - NeuroSearch (NEUR) today reported positive
top-line results from the MermaiHD study, the European Phase III study with
Huntexil® (pridopidine) in Huntington's disease.

The MermaiHD study met the primary endpoint to show an effect on voluntary
motor function. In addition, data from the 437 Huntington patients, who
participated in the study (= ITT population) show that six months' (26 weeks)
treatment with Huntexil® results in significant improvements in a broader range
of voluntary and involuntary motor symptoms associated with the disease. The
study was conducted in 32 centres across Europe, and showed a very high
compliance with 92% of the patients completing the study and 82% in full
compliance with the study.

Treatment with Huntexil® 45 mg BID (twice daily) demonstrated statistically and
clinically significant improvements compared to placebo in the ITT population
on the following measures of motor symptoms in Huntington's disease:

Symptoms scale; Significance level; Description:

Modified Motor Score, mMS; ITT: p <0.02;The mMS is the primary efficacy measure
of the MermaiHD study, and assesses voluntary motor function as part of the TMS

Total Motor Score, TMS; ITT: p <0.001; The TMS is the motor part of the Unified
Huntington's Disease Rating Scale (UHDRS) and measures overall motor effects
including both voluntary and involuntary motor symptoms

Eye Movements; ITT: p <0.002; Eye movements are voluntary movements but not
included in the mMS

Dystonia; ITT: p <0.001; Dystonia is part of the involuntary motor symptoms and
included also in the TMS
?
Treatment with Huntexil® 45 mg QD (once daily) showed some improvements on
these motor function domains, however did not reach statistical significance.

The improvements in motor function observed with Huntexil® 45 mg twice daily in
the MermaiHD study appear very robust, as they (1) remain consistent across
assessments and analyses, (2) show increasing separation from placebo over
time, and (3) are consistent also across the two pre-stratified study groups of
patients on use/non-use of antipsychotic medication; approximately 40% of
patients were on antipsychotics. The importance of studying both patient groups
has been emphasized by experts and regulators to demonstrate that Huntexil®
improves the symptoms of Huntington's disease per se, and that it is also safe
in patients treated with antipsychotics. The use of antipsychotics showed no
influence on the positive treatment effects of Huntexil®.

In the study, Huntexil® was generally very well tolerated with an adverse event
profile similar to placebo, and the results show no indication that treatment
with Huntexil® would be associated with worsening of disease signs and
symptoms.

Following the results, NeuroSearch is now initiating interactions with
scientific advisors and regulatory agencies (EMEA and FDA) to discuss the
MermaiHD study outcome and the plans for submissions for market authorisation
for Huntexil® as a novel treatment for Huntington's disease.

Principal investigator, Prof. Justo García de Yébenes, Hospital Ramon y Cajal,
Madrid, Spain, commented:
"Huntington's disease is a progressive disorder with motor, cognitive, and
behavioral symptoms. Huntexil® is the first medication to have demonstrated an
overall improvement of the motor impairment in Huntington patients with no
worsening of other signs or symptoms and without compromising patient safety.
Overall, the MermaiHD study results show that Huntexil® has a favorable
clinical risk/benefit profile, and I believe it could be useful to many of my
patients."

Chairman of the European Huntington's Disease Network, EHDN, Prof. G.B.
Landwehrmeyer, commented:
"The EHDN is very proud to have been part of making the MermaiHD study a
success both in terms of quality and time. With more than 400 patients
participating, the trial is one of the largest so far conducted in Huntington's
disease in Europe, and recruitment was completed within one year. I would like
to thank all participants and their caregivers, all investigators and their
staff as well as the employees at the EHDN for their dedicated contribution to
this achievement."

Flemming Pedersen, CEO of NeuroSearch, commented:
"The Phase III results from the MermaiHD study are very encouraging,
demonstrating that Huntexil® can provide significant benefits to Huntington
patients on symptoms not reached by any current treatment, and this without any
"trade-offs" in terms of safety or worsening of any other disease symptoms. We
remain determined to bring Huntexil® forward as a new medication to patients
with Huntington's disease and we will work closely with physicians and
regulatory authorities to make this happen as soon as possible."

NeuroSearch is also evaluating Huntexil® in a second randomised and
placebo-controlled study, the HART study, conducted in the USA and Canada and
in approximately 220 patients with Huntington's disease. Patient recruitment
in the HART study is still ongoing, and study results are expected in the
second half of 2010.

Also, the MermaiHD study is followed by an open-label treatment period, which
is still ongoing. Patients, who completed the six months' randomised study
treatment, have been offered to continue open-label treatment with up to 45 mg
Huntexil® twice daily for six months. Close to 90% of the patients have chosen
to continue treatment in the open-label phase, and the last patient is expected
to complete the full 12 months treatment period in May 2010. Results from the
open-label treatment period are also expected to be available in the second
half of 2010.

NeuroSearch will give financial guidance for 2010 in connection with release of
the 2009 Annual Report on 10 March 2010.

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 4460 8212 or +45 4017 5103

Conference call on the results of the MermaiHD study
NeuroSearch will host a conference call today at 3pm CET (9am EST) to present
and discuss the results from the MermaiHD study with Huntexil®. Participating
in the call will be CEO Flemming Pedersen, Chief Medical Officer Dr. Dieter
Meier, Head of Clinical Science Dr. Joakim Tedroff, and Director of Investor &
Capital Market Relations Hanne Leth Hillman. The conference call will be
conducted in English and can be accessed and followed via a link on
NeuroSearch's website www.neurosearch.com. To participate in the questions and
answers session following the presentation, please dial: DK +45 3271 4767, UK
+44 207 509 5139, US +1 718 354 1226 or International +44 207 509 5139.


About Huntexil® (pridopidine) - A dopaminergic stabiliser
Pridopidine acts as a dopaminergic stabiliser and is the first in a new class
of active agents, which has the unique ability to stabilise the dopaminergic
system, i.e., to either enhance or inhibit dopamine dependent functions in the
brain, depending on the initial level of dopaminergic activity.
Pridopidine inhibits dopamine activation of the D2 receptor with a preference
towards the high affinity (activated) receptor state and has no detectable
agonist activity on this receptor. In vivo, pridopidine strengthens glutamate
function in the frontal cortex, which may add to the agent's powerful
behavioural effects in states of excessively high dopamine activity or
excessively low glutamate activity, while not affecting behaviour under normal
conditions. Together, these findings suggest that pridopidine stabilises
psychomotor activity in states of hypo- and hyperactivity by means of
functional D2 antagonism and strengthening of cortical glutamate functions.
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 without compromising
normal brain functions.

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 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) 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.




Der er endnu ikke skrevet nogen kommentarer til denne artikel.

Skriv en kommentarer til denne artikel:


Send kommentar


Kursinfo - NeuroSearch

PRIS 3,50
ÆNDRING -0,01 (-0,28%)
ÅBEN 3,57
SIDSTE LUK 3,51
DEBAT -
OMX Børsmeddelelser

RELATEREDE NYHEDER