This is huge. Countdown for the cure. It can only go up from here.
Copenhagen, DENMARK September 15, 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.
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 diseaseHuntington'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 profileNeuroSearch (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.
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