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Neurosearch A/S (NEUR.CO) Announces New Findings From the MermaiHD Phase III Study Supporting Potential Disease Modifying Properties of Huntexil(R)



3/8/2010 11:46:53 AM

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.

Read at BioSpace.com


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