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Good News!! Positive Top-line Results From Phase III Huntexil(R) Study in HD

NeuroSearch Announces Positive Top-line Results From Phase III Huntexil(R) Study in Huntington's Disease (the MermaiHD Study)

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

COPENHAGEN and BALLERUP, Denmark, Feb. 3, 2010 (GLOBE NEWSWIRE) -- NeuroSearch (NEUR) today reported positive top-line results from the MermaiHD study, the European Phase III study with Huntexil(R) (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(R) 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(R) 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    ITT: p <0.02        The mMS is the primary efficacy
 Score, mMS                            measure of the MermaiHD study,
                                       and assesses voluntary motor
                                       function as part of the TMS
 ----------------------------------------------------------------------
 Total Motor       ITT: p <0.001       The TMS is the motor part of the
 Score, TMS                            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(R) 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(R) 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(R) 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(R).

In the study, Huntexil(R) was generally very well tolerated with an adverse event profile similar to placebo, and the results show no indication that treatment with Huntexil(R) 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(R) as a novel treatment for Huntington's disease.
Principal investigator, Prof. Justo Garcia de Yebenes, Hospital Ramon y Cajal, Madrid, Spain, commented:

"Huntington's disease is a progressive disorder with motor, cognitive, and behavioral symptoms. Huntexil(R) 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(R) 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(R) 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(R) 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(R) 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(R) 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.

There will be a 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(R). 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, U.S. +1 718 354 1226 or International +44 207 509 5139.

About Huntexil(R) (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(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 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(R) 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(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